This section highlights FDA-related milestones and regulatory updates for drugs developed by KalVista Pharmaceuticals (KALV).
Over the past two years, KalVista Pharmaceuticals has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
KONFIDENT, KONFIDENT-KID, KONFIDENT-S, and sebetralstat. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
KONFIDENT - FDA Regulatory Timeline and Events
KONFIDENT is a drug developed by KalVista Pharmaceuticals for the following indication: Treatment of HAE attacks in adults and adolescents aged 12 years and older.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- KONFIDENT
- Announced Date:
- October 4, 2024
- Indication:
- Treatment of HAE attacks in adults and adolescents aged 12 years and older.
Announcement
KalVista Pharmaceuticals, Inc announced that it presented data showing the effectiveness of sebetralstat in reducing anxiety among people experiencing hereditary angioedema (HAE) attacks at the HAEi Global Angioedema Forum (GAF) taking place in Copenhagen, Denmark, October 4 - 5, 2024.
AI Summary
KalVista Pharmaceuticals recently presented promising data at the HAEi Global Angioedema Forum in Copenhagen demonstrating that sebetralstat, an investigational oral plasma kallikrein inhibitor, effectively reduces anxiety during hereditary angioedema (HAE) attacks. This phase 3 KONFIDENT trial data showed that patients experienced significant anxiety relief with both 300 mg and 600 mg doses compared to placebo, as measured by a modified anxiety rating scale. Notably, greater anxiety reduction was observed among those with moderate-to-extreme anxiety, with improvements corresponding to an earlier onset of symptom relief.
If approved, sebetralstat could offer a user-friendly on-demand treatment alternative to current injectable therapies. By lowering treatment-related anxiety and streamlining the attack management process, the oral formulation may enhance quality of life for HAE patients, allowing them to treat attacks earlier and potentially recover more quickly.
Read Announcement
KONFIDENT-KID - FDA Regulatory Timeline and Events
KONFIDENT-KID is a drug developed by KalVista Pharmaceuticals for the following indication: oral plasma kallikrein inhibitor, in pediatric patients between the ages of two and 11 with hereditary angioedema (HAE).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- KONFIDENT-KID
- Announced Date:
- March 25, 2025
- Indication:
- oral plasma kallikrein inhibitor, in pediatric patients between the ages of two and 11 with hereditary angioedema (HAE).
Announcement
KalVista Pharmaceuticals, Inc announced the completion of enrollment in the open-label KONFIDENT-KID clinical trial of sebetralstat, an investigational, novel, oral plasma kallikrein inhibitor, in pediatric patients between the ages of two and 11 with hereditary angioedema (HAE).
AI Summary
KalVista Pharmaceuticals, Inc. recently announced the completion of enrollment in its KONFIDENT-KID trial testing sebetralstat, an investigational oral plasma kallikrein inhibitor, in pediatric patients aged two to 11 with hereditary angioedema (HAE). Achieving target enrollment a year ahead of schedule, the trial expanded from an original 24 patients to roughly 36 participants across seven countries in North America, Europe, and Asia. CEO Ben Palleiko highlighted the strong participation from families affected by HAE, emphasizing the significant need for an oral treatment option for young patients. The study will collect safety, pharmacokinetic, and efficacy data over one year, and it offers hope for replacing the current intravenous treatment. Researchers expect initial data release later this year, with a regulatory submission planned by mid-2026.
Read Announcement
KONFIDENT-S - FDA Regulatory Timeline and Events
KONFIDENT-S is a drug developed by KalVista Pharmaceuticals for the following indication: Treatment of hereditary angioedema (HAE) attacks in adult and pediatric patients aged 12 years and older.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- KONFIDENT-S
- Announced Date:
- June 16, 2025
- Indication:
- Treatment of hereditary angioedema (HAE) attacks in adult and pediatric patients aged 12 years and older.
Announcement
KalVista Pharmaceuticals, Inc announced the presentation of new data at the European Academy of Allergy and Clinical Immunology (EAACI) Congress 2025 in Glasgow, United Kingdom that underscores the critical role of effective on-demand (OD) treatment for HAE attacks among patients receiving long-term prophylaxis (LTP).
AI Summary
KalVista Pharmaceuticals recently presented new data at the EAACI Congress 2025 in Glasgow, underscoring the importance of effective on-demand treatment for HAE attacks in patients receiving long-term prophylaxis (LTP). The interim analysis from the KONFIDENT-S study, which involved 35 patients using LTP options like berotralstat, lanadelumab, or C1 inhibitor, showed that breakthrough attacks still occur despite ongoing prophylaxis. Sebetralstat was used as an on-demand treatment for 382 documented attacks, with a median treatment time of 6 minutes and symptom relief beginning approximately 1.3 hours after administration. Dr. Marc A. Riedl highlighted that these findings emphasize the need for a fast-acting, easy-to-administer oral treatment that can complement various LTP therapies, addressing the critical gaps in current HAE management.
Read Announcement- Drug:
- KONFIDENT-S
- Announced Date:
- September 6, 2024
- Indication:
- Treatment of hereditary angioedema (HAE) attacks in adult and pediatric patients aged 12 years and older.
Announcement
KalVista Pharmaceuticals, Inc announced that it presented additional analyses of the efficacy and safety of sebetralstat from phase 2 and phase 3 double-blind, placebo-controlled crossover clinical trials as well as interim data from KONFIDENT-S, a phase 3 open-label extension trial, and real-world patient data at the Bradykinin Symposium 2024 taking place in Berlin, Germany, on September 5-6.
AI Summary
KalVista Pharmaceuticals recently shared new findings on sebetralstat at the Bradykinin Symposium 2024 in Berlin, Germany. The company presented additional analyses from phase 2 and phase 3 double-blind, placebo-controlled crossover clinical trials that supported the efficacy and safety of sebetralstat, a promising oral plasma kallikrein inhibitor intended for on-demand treatment of hereditary angioedema (HAE) attacks. They also released interim data from the KONFIDENT-S phase 3 open-label extension trial, along with real-world patient data. These studies showed that sebetralstat has a safety profile comparable to placebo and may offer quick symptom relief. The data suggest that this investigational oral therapy could be a significant advancement for both adult and pediatric HAE patients, addressing some of the challenges that come with the current injection-based treatments.Read Announcement
sebetralstat - FDA Regulatory Timeline and Events
sebetralstat is a drug developed by KalVista Pharmaceuticals for the following indication: Therapy for hereditary angioedema (HAE).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- sebetralstat
- Announced Date:
- July 7, 2025
- Indication:
- Therapy for hereditary angioedema (HAE).
Announcement
KalVista Pharmaceuticals, Inc announced that the U.S. Food and Drug Administration (FDA) has approved EKTERLY® (sebetralstat), a novel plasma kallikrein inhibitor, for the treatment of acute attacks of hereditary angioedema (HAE) in adult and pediatric patients aged 12 years and older. EKTERLY is the first and only oral on-demand treatment for HAE.
AI Summary
KalVista Pharmaceuticals has received FDA approval for EKTERLY® (sebetralstat), a novel plasma kallikrein inhibitor for hereditary angioedema (HAE). This is the first and only oral on-demand treatment available for both adults and pediatric patients aged 12 and older. Unlike previous therapies that required injections, EKTERLY offers a convenient pill form that allows patients to treat acute HAE attacks as soon as symptoms begin.
Approved by the U.S. FDA, EKTERLY is designed to rapidly relieve symptoms and resolve HAE attacks regardless of their location or severity. This advancement provides a much-needed alternative that can offer patients greater independence and timely treatment, potentially transforming the way HAE is managed.
Read Announcement- Drug:
- sebetralstat
- Announced Date:
- June 13, 2025
- Indication:
- Therapy for hereditary angioedema (HAE).
Announcement
KalVista Pharmaceuticals, Inc announced that the U.S. Food and Drug Administration (FDA) has notified the Company that it will not meet the PDUFA goal date for the New Drug Application (NDA) for sebetralstat, the Company's investigational oral on-demand treatment for hereditary angioedema (HAE). The FDA notified the Company on June 13, 2025, that the previously disclosed June 17, 2025 PDUFA goal date will not be met due to heavy workload and limited resources. The FDA indicated that it expects to deliver a decision within approximately four weeks.
AI Summary
KalVista Pharmaceuticals recently announced that the FDA informed them the PDUFA goal date of June 17, 2025, for its New Drug Application for sebetralstat will not be met. The agency cited a heavy workload and limited resources as reasons for the delay and noted this update on June 13, 2025. Despite the setback, the FDA expects to deliver a decision within approximately four weeks. Importantly, the agency has not requested any additional data or raised concerns about the safety, efficacy, or approvability of the treatment.
KalVista expressed its disappointment over the delay because of the high expectations of patients with hereditary angioedema (HAE) for a convenient oral, on-demand option. The company remains confident in the near-term approval of sebetralstat and continues to work closely with the FDA during the final stages of the review process.
Read Announcement- Drug:
- sebetralstat
- Announced Date:
- June 5, 2025
- Indication:
- Therapy for hereditary angioedema (HAE).
Announcement
KalVista Pharmaceuticals, announced the acceptance of six scientific abstracts at the European Academy of Allergy and Clinical Immunology (EAACI) Congress 2025 taking place in Glasgow, United Kingdom from June 13–16, 2025.
AI Summary
KalVista Pharmaceuticals has announced that six scientific abstracts have been accepted for presentation at the European Academy of Allergy and Clinical Immunology (EAACI) Congress 2025. The event will be held in Glasgow, United Kingdom, from June 13 to 16, 2025. The accepted abstracts cover various aspects of hereditary angioedema (HAE) treatment with a key focus on the novel oral plasma kallikrein inhibitor, sebetralstat. Presentations include poster sessions, oral talks, and flash talks that discuss topics such as managing pseudo-allergic reactions, the psychological and treatment burdens in HAE, adherence to long-term prophylaxis, and the impact of delayed treatment on HAE attacks. Additionally, KalVista is sponsoring a symposium on HAE management to help close gaps in the treatment of HAE. This initiative underscores the company’s commitment to developing effective, on-demand, oral therapies for HAE patients.
Read Announcement- Drug:
- sebetralstat
- Announced Date:
- May 22, 2025
- Indication:
- Therapy for hereditary angioedema (HAE).
Announcement
KalVista Pharmaceuticals, Inc. announced that it will present new sebetralstat data at two upcoming congresses taking place concurrently from May 29–June 1, 2025: the 14th C1-inhibitor Deficiency & Angioedema Workshop in Budapest, Hungary, and the Eastern Allergy Conference (EAC) in Palm Beach, Florida.
AI Summary
KalVista Pharmaceuticals announced it will present new sebetralstat data at two upcoming congresses from May 29 to June 1, 2025. The data will be shown at the 14th C1-inhibitor Deficiency & Angioedema Workshop in Budapest, Hungary, and at the Eastern Allergy Conference in Palm Beach, Florida. Researchers will share findings that highlight sebetralstat’s ability to rapidly relieve symptoms of hereditary angioedema attacks, including mucosal and severe cases. The presentations will focus on the benefits of early intervention by using the investigational oral plasma kallikrein inhibitor to halt attack progression. This initiative signals progress in finding effective, patient-friendly therapies for hereditary angioedema and highlights KalVista’s commitment to meeting patient needs.
Read Announcement- Drug:
- sebetralstat
- Announced Date:
- March 25, 2025
- Indication:
- Therapy for hereditary angioedema (HAE).
Announcement
KalVista Pharmaceuticals, Inc announced the completion of enrollment in the open-label KONFIDENT-KID clinical trial of sebetralstat, an investigational, novel, oral plasma kallikrein inhibitor, in pediatric patients between the ages of two and 11 with hereditary angioedema (HAE).
AI Summary
KalVista Pharmaceuticals announced that enrollment is now complete in its KONFIDENT-KID clinical trial, which is testing sebetralstat, a novel oral plasma kallikrein inhibitor, in children aged 2 to 11 with hereditary angioedema (HAE). The trial, originally planned for 24 patients, expanded to include around 36 participants due to strong interest from families seeking a more convenient treatment option. Unlike current on-demand treatments that require intravenous administration, sebetralstat is being developed as an oral therapy, featuring a unique pediatric oral disintegrating tablet formulation. The study aims to gather important safety, pharmacokinetic, and efficacy data over the course of up to one year. Initial results are expected later this year, and the company plans to file a supplemental New Drug Application by mid-2026, highlighting the significant demand for effective and less invasive HAE treatments for young patients.
Read Announcement- Drug:
- sebetralstat
- Announced Date:
- March 12, 2025
- Indication:
- Therapy for hereditary angioedema (HAE).
Announcement
KalVista Pharmaceuticals, Inc provided an operational update.
AI Summary
KalVista Pharmaceuticals, Inc. provided an operational update during its third fiscal quarter report, highlighting significant progress with its investigational drug sebetralstat. The company submitted its seventh global regulatory application, including a New Drug Application to Japan’s Ministry of Health, Labour and Welfare (MHLW), which has also granted sebetralstat orphan drug designation. This milestone underscores KalVista’s commitment to establishing sebetralstat as the first and only on-demand, oral treatment for hereditary angioedema (HAE).
Furthermore, the update noted that robust clinical data support the potential of sebetralstat to address critical unmet needs in patients, such as those experiencing laryngeal attacks or HAE attacks despite long-term prophylaxis, and in adolescents. KalVista plans to host a virtual investor day to review its commercialization strategy ahead of the June PDUFA goal date.
Read Announcement- Drug:
- sebetralstat
- Announced Date:
- March 3, 2025
- Indication:
- Therapy for hereditary angioedema (HAE).
Announcement
KalVista Pharmaceuticals, Inc announced the presentation of novel sebetralstat data related to laryngeal hereditary angioedema (HAE) attacks and adolescents with HAE at the American Academy of Allergy, Asthma & Immunology (AAAAI) / World Allergy Organization (WAO) 2025 Joint Congress taking place in San Diego, CA from February 28–March 3, 2025.
AI Summary
KalVista Pharmaceuticals, Inc. announced that it will present novel sebetralstat data at the AAAAI/WAO 2025 Joint Congress in San Diego, CA, from February 28 to March 3, 2025. The data show that sebetralstat, an investigational oral plasma kallikrein inhibitor, can provide prompt treatment for laryngeal hereditary angioedema (HAE) attacks with a median onset of symptom relief in about 1 hour and 16 minutes.
Pooled analysis of adolescent patients revealed that treatment with sebetralstat was initiated in a median of 4 minutes after an attack onset, a significant improvement compared to existing injectable on-demand therapies. This fast response could be crucial in managing potentially life-threatening laryngeal attacks and reducing delays in treatment, offering a promising oral alternative for patients, especially adolescents, who currently face limited options.
Read Announcement- Drug:
- sebetralstat
- Announced Date:
- February 21, 2025
- Indication:
- Therapy for hereditary angioedema (HAE).
Announcement
KalVista Pharmaceuticals, Inc. announced that six abstracts have been accepted for presentation at the American Academy of Allergy, Asthma & Immunology (AAAAI) / World Allergy Organization (WAO) 2025 Joint Congress taking place in San Diego, CA from February 28–March 3, 2025.
AI Summary
KalVista Pharmaceuticals, Inc. announced that six abstracts have been accepted for presentation at the American Academy of Allergy, Asthma & Immunology (AAAAI) / World Allergy Organization (WAO) 2025 Joint Congress. The event will be held in San Diego, CA, between February 28 and March 3, 2025. The presentations will highlight key findings on the treatment of hereditary angioedema (HAE), including issues such as barriers to timely on-demand treatment, challenges faced by adolescents, and delays in treatment across various healthcare systems. In addition, late-breaking data on the use of sebetralstat, KalVista’s novel oral plasma kallikrein inhibitor, will be shared. These studies aim to provide new insights into HAE management and improve patient outcomes by addressing both practical and clinical challenges in on-demand treatment strategies.
Read Announcement- Drug:
- sebetralstat
- Announced Date:
- February 10, 2025
- Indication:
- Therapy for hereditary angioedema (HAE).
Announcement
KalVista Pharmaceuticals, Inc announced the presentation of novel data related to long-term prophylaxis and sebetralstat at the Western Society of Allergy, Asthma & Immunology (WSAAI) 2025 Annual Meeting taking place in Waimea, HI from February 9-13, 2025.
AI Summary
KalVista Pharmaceuticals, Inc. announced the presentation of new data on long-term prophylaxis (LTP) and sebetralstat at the Western Society of Allergy, Asthma & Immunology (WSAAI) 2025 Annual Meeting in Waimea, HI, from February 9–13, 2025. The data showed that nearly 40% of hereditary angioedema (HAE) patients on LTP experienced significant prescription refill gaps, which did not reduce the need for on-demand treatment. These gaps may lead to higher discontinuation rates of LTP, highlighting a need for improved patient monitoring and adherence strategies.
Additionally, interim analyses from the KONFIDENT-S study revealed that sebetralstat, an investigational oral plasma kallikrein inhibitor, enabled rapid early treatment of HAE attacks, with median symptom relief in about 1.3 hours. These promising results suggest that, if approved, sebetralstat could become a safe and effective on-demand treatment option for patients, regardless of the type of LTP they are using.
Read Announcement- Drug:
- sebetralstat
- Announced Date:
- January 21, 2025
- Indication:
- Therapy for hereditary angioedema (HAE).
Announcement
KalVista Pharmaceuticals, Inc. announced that Japan's Ministry of Health, Labour and Welfare (MHLW) has granted sebetralstat Orphan Drug Designation.
AI Summary
KalVista Pharmaceuticals recently announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has granted orphan drug designation to its investigational drug, sebetralstat. This designation is an important milestone that recognizes the urgent need for new and effective treatments for hereditary angioedema (HAE) in Japan. If approved, sebetralstat would become the first oral on-demand treatment for HAE, offering an alternative to intravenous or subcutaneous treatments currently available in the country.
The company has also submitted a New Drug Application (NDA) for sebetralstat in Japan as part of its global strategy to meet the needs of HAE patients. The orphan drug designation by MHLW is expected to support the regulatory process and accelerate the availability of this novel treatment to adults and adolescents aged 12 years and older living with HAE.
Read Announcement- Drug:
- sebetralstat
- Announced Date:
- October 4, 2024
- Indication:
- Therapy for hereditary angioedema (HAE).
Announcement
KalVista Pharmaceuticals, Inc. announced that it presented data showing the effectiveness of sebetralstat in reducing anxiety among people experiencing hereditary angioedema (HAE) attacks at the HAEi Global Angioedema Forum (GAF) taking place in Copenhagen, Denmark, October 4 - 5, 2024.
AI Summary
KalVista Pharmaceuticals presented new data at the HAEi Global Angioedema Forum in Copenhagen, Denmark, showing that sebetralstat can effectively reduce anxiety during hereditary angioedema (HAE) attacks. The data, from the KONFIDENT phase 3 clinical trial, revealed that patients treated with sebetralstat reported a significant decrease in anxiety compared to those given a placebo. This reduction was especially notable in individuals experiencing moderate-to-extreme anxiety, and it was linked to an earlier onset of symptom relief.
By offering an oral on-demand treatment option, sebetralstat could provide a more convenient alternative to injectable therapies. KalVista emphasized that lowering anxiety during attacks may improve overall quality of life for HAE patients, potentially allowing them to treat attacks earlier and recover more quickly. The results support the need for innovative treatments to address both the physical and emotional challenges of HAE attacks.
Read Announcement- Drug:
- sebetralstat
- Announced Date:
- September 30, 2024
- Indication:
- Therapy for hereditary angioedema (HAE).
Announcement
KalVista Pharmaceuticals, Inc announced Marketing Authorization Application (MAA) submissions to the regulatory authorities in the United Kingdom, Switzerland, Australia, and Singapore for sebetralstat, a novel, investigational oral plasma kallikrein inhibitor for the on-demand treatment of hereditary angioedema (HAE) attacks in adults and adolescents aged 12 years and older.
AI Summary
KalVista Pharmaceuticals, Inc has submitted Marketing Authorization Applications (MAAs) to regulatory authorities in the United Kingdom, Switzerland, Australia, and Singapore for its investigational drug, sebetralstat. This novel oral plasma kallikrein inhibitor is designed for the on-demand treatment of hereditary angioedema (HAE) attacks in adults and adolescents aged 12 years and older. If approved, sebetralstat would become the first oral on-demand treatment option for HAE, offering a new approach to manage this rare and potentially life-threatening condition characterized by painful swelling. The applications were submitted under the Access Consortium framework, a collaborative effort among the Medicines and Healthcare products Regulatory Agency, Swissmedic, the Therapeutic Goods Administration, and the Health Sciences Authority, which aims to streamline the review process. This move underscores KalVista’s commitment to expanding global access and addressing the unmet needs of HAE patients worldwide.
Read Announcement- Drug:
- sebetralstat
- Announced Date:
- September 3, 2024
- Indication:
- Therapy for hereditary angioedema (HAE).
Announcement
KalVista Pharmaceuticals, Inc announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for sebetralstat, a novel, investigational oral plasma kallikrein inhibitor for the on-demand treatment of hereditary angioedema (HAE) attacks in adult and pediatric patients aged 12 years and older.
AI Summary
KalVista Pharmaceuticals has announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for sebetralstat. This novel, investigational oral plasma kallikrein inhibitor is designed for the on-demand treatment of hereditary angioedema (HAE) attacks in adult and pediatric patients aged 12 years and older. If approved, sebetralstat will be the first oral treatment option to rapidly address HAE attacks, providing patients with a more convenient alternative to the current intravenous or subcutaneous therapies. The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date of June 17, 2025, for its review and decision. KalVista’s announcement marks an important milestone in developing a transformative therapy that could significantly improve the quality of life for those living with HAE by offering quicker and easier management of their condition.
Read Announcement- Drug:
- sebetralstat
- Announced Date:
- September 3, 2024
- Estimated Event Date Range:
- June 17, 2025 - June 17, 2025
- Target Action Date:
- June 17, 2025
- Indication:
- Therapy for hereditary angioedema (HAE).
Announcement
KalVista Pharmaceuticals, Inc announced that The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date of June 17, 2025
AI Summary
KalVista Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has set a Prescription Drug User Fee Act (PDUFA) goal date of June 17, 2025, for its investigational treatment, sebetralstat. This novel oral plasma kallikrein inhibitor is being developed for the on-demand treatment of hereditary angioedema (HAE) attacks in patients aged 12 years and older. If the drug is approved, it would be the first oral on-demand treatment available for HAE, offering patients a potentially easier and faster option compared to current therapies that require injections.
KalVista expressed optimism about the NDA acceptance, highlighting strong support from healthcare providers, patients, and advocates. The company believes that sebetralstat could transform HAE management, providing timely relief during unpredictable and sometimes life-threatening attacks. The FDA's goal date marks a significant milestone in the development of this innovative treatment.
Read Announcement- Drug:
- sebetralstat
- Announced Date:
- August 15, 2024
- Indication:
- Therapy for hereditary angioedema (HAE).
Announcement
KalVista Pharmaceuticals, Inc announced that the European Medicines Agency (EMA) has validated the submission of a Marketing Authorization Application (MAA) for sebetralstat, a novel, investigational oral plasma kallikrein inhibitor for the on-demand treatment of hereditary angioedema (HAE).
AI Summary
KalVista Pharmaceuticals has reached a key regulatory milestone as the European Medicines Agency (EMA) validated its Marketing Authorization Application (MAA) for sebetralstat. This novel, investigational oral plasma kallikrein inhibitor is designed for the on-demand treatment of hereditary angioedema (HAE), a rare genetic disorder characterized by sudden and severe swelling attacks. The EMA’s decision means that the application will now be reviewed by the Committee for Medicinal Products for Human Use (CHMP) under a centralized licensing process applicable to all 27 EU member states and additional EEA countries such as Norway, Iceland, and Liechtenstein.
If approved, sebetralstat would be the first oral, on-demand treatment for HAE in Europe, offering patients a potentially more convenient alternative to current methods and addressing significant unmet needs in HAE care.
Read Announcement- Drug:
- sebetralstat
- Announced Date:
- July 11, 2024
- Indication:
- Therapy for hereditary angioedema (HAE).
Announcement
KalVista Pharmaceuticals, Inc. announced that it has submitted FDA Application for Sebetralstat
AI Summary
KalVista Pharmaceuticals, Inc. recently submitted a New Drug Application for sebetralstat to the FDA. This investigational drug is designed as the first oral, on-demand treatment for hereditary angioedema (HAE) attacks in patients 12 years and older. The FDA submission marks a significant milestone for the HAE community, aiming to fill an unmet need with a novel treatment option. KalVista projects the potential FDA approval and launch of sebetralstat in the first half of 2025, which would offer patients safer and more convenient management of HAE episodes. The company’s commitment is further underlined by its ongoing clinical work, including pediatric trials with an orally disintegrating tablet formulation. This regulatory step is a key element in the company’s strategy to expand treatment options globally through future marketing authorization applications with various national health authorities.
Read Announcement- Drug:
- sebetralstat
- Announced Date:
- July 11, 2024
- Indication:
- Therapy for hereditary angioedema (HAE).
Announcement
KalVista Pharmaceuticals, Inc announced that it has Phase 3 Trial Results Published
AI Summary
KalVista Pharmaceuticals recently announced that the Phase 3 KONFIDENT trial results for its investigational drug sebetralstat were published in The New England Journal of Medicine. The publication highlights the robust data supporting sebetralstat as a promising oral, on-demand treatment for hereditary angioedema (HAE) attacks. The study results reinforce the drug's potential to offer a convenient alternative to current therapies, which could benefit both adults and pediatric patients aged 12 and older. KalVista believes these findings are a strong indicator of the treatment’s effectiveness and safety. The company is preparing additional regulatory submissions around the world and anticipates a potential U.S. approval and launch in the first half of 2025.
Read Announcement- Drug:
- sebetralstat
- Announced Date:
- June 27, 2024
- Indication:
- Therapy for hereditary angioedema (HAE).
Announcement
KalVista Pharmaceuticals, Inc announced the initiation of the open-label KONFIDENT-KID clinical trial of sebetralstat, a novel, oral, plasma kallikrein inhibitor, in pediatric patients with hereditary angioedema (HAE).
AI Summary
KalVista Pharmaceuticals recently announced the start of its open-label KONFIDENT-KID clinical trial for sebetralstat, an innovative oral plasma kallikrein inhibitor. The trial aims to enroll around 24 pediatric patients aged 2 to 11 years across seven countries in North America, Europe, and Asia. Over the course of up to one year, the study will collect important safety, pharmacokinetic, and efficacy data. A key feature of the trial is the use of a specially formulated pediatric oral disintegrating tablet (ODT) designed to address an unmet need in treating hereditary angioedema (HAE) in children. If successful, sebetralstat could become the first oral on-demand treatment for this age group, offering a significant alternative to the currently available intravenous therapy for pediatric HAE patients.
Read Announcement- Drug:
- sebetralstat
- Announced Date:
- June 18, 2024
- Indication:
- Therapy for hereditary angioedema (HAE).
Announcement
KalVista intends to present additional data from the KONFIDENT and KONFIDENT-S trials at the 2024 Annual Scientific Conference of the American College of Allergy, Asthma, and Immunology (ACAAI) Conference on October 24-28, 2024, in Boston, Massachusetts.
AI Summary
KalVista Pharmaceuticals plans to share important new data at the upcoming 2024 Annual Scientific Conference of the American College of Allergy, Asthma, and Immunology in Boston, Massachusetts, scheduled for October 24-28, 2024. The company will present further findings from its KONFIDENT and KONFIDENT-S trials, which are designed to evaluate sebetralstat, an innovative oral plasma kallikrein inhibitor intended for the on-demand treatment of hereditary angioedema (HAE) attacks. These trials investigate the treatment’s ability to quickly relieve symptoms while maintaining a strong safety profile. KalVista’s upcoming presentation at this prominent conference highlights its commitment to addressing the unmet needs of the HAE community by offering new therapeutic options. The data sharing is expected to foster dialogue among specialists in allergy, asthma, and immunology, potentially advancing the understanding and management of HAE through this novel oral treatment approach.
Read Announcement- Drug:
- sebetralstat
- Announced Date:
- June 18, 2024
- Indication:
- Therapy for hereditary angioedema (HAE).
Announcement
KalVista Pharmaceuticals, Inc announced the submission of a New Drug Application (NDA) for U.S. Food and Drug Administration (FDA) review of sebetralstat, a novel investigational oral plasma kallikrein inhibitor for the on-demand treatment of hereditary angioedema (HAE) attacks in adults and pediatric patients aged 12 years and older.
AI Summary
KalVista Pharmaceuticals has submitted a New Drug Application (NDA) to the FDA for sebetralstat, a new oral plasma kallikrein inhibitor designed to treat hereditary angioedema (HAE) attacks on demand. The treatment targets adults and pediatric patients aged 12 years and older, offering a more convenient alternative to injectable therapies. If approved, sebetralstat would be the first oral, on-demand treatment available for HAE, potentially making a significant impact on patient care by providing faster, easier relief during attacks. This milestone submission is based on promising clinical trial data showing that sebetralstat provides rapid symptom relief compared to placebo. KalVista’s effort aims to address long-standing unmet needs within the HAE community, and the FDA will evaluate the application over the next 60 days to determine if the drug will move forward in its review process.
Read Announcement- Drug:
- sebetralstat
- Announced Date:
- June 6, 2024
- Indication:
- Therapy for hereditary angioedema (HAE).
Announcement
KalVista Pharmaceuticals, Inc announced that it presented the US subgroup analysis from the sebetralstat phase 3 KONFIDENT trial and real-world claims and patient survey data at the Eastern Allergy Conference (EAC) 2024, as well as the Japanese subgroup from KONFIDENT at the 123rd Annual Meeting of the Japanese Dermatological Association (JDA) 2024. KONFIDENT is the first pivotal phase 3 trial to include Japanese sites in an HAE development program.
AI Summary
KalVista Pharmaceuticals recently presented key data from its phase 3 KONFIDENT trial at two major events. At the Eastern Allergy Conference (EAC) 2024 in the US, the company shared subgroup analysis results demonstrating that sebetralstat, its on-demand therapy for hereditary angioedema (HAE), yielded a median time to treatment of 38 minutes and symptom relief starting in about 1.3 hours. Real-world claims and survey data were also presented, indicating that despite increased use of long-term prophylaxis therapies, on-demand treatment volumes remain stable, and non-prescription healthcare costs continue to be high.
Additionally, at the 123rd Annual Meeting of the Japanese Dermatological Association (JDA) 2024, KalVista presented data from the Japanese subgroup. KONFIDENT is noted as the first pivotal phase 3 HAE trial to include Japanese sites, marking a significant milestone in expanding the study globally.
Read Announcement- Drug:
- sebetralstat
- Announced Date:
- May 24, 2024
- Indication:
- Therapy for hereditary angioedema (HAE).
Announcement
KalVista Pharmaceuticals, Inc announced the acceptance of multiple abstracts and a symposium at the European Academy of Allergy and Clinical Immunology (EAACI) Congress 2024 taking place in Valencia, Spain from May 31-June 3.
AI Summary
KalVista Pharmaceuticals, Inc. announced that multiple abstracts and a symposium have been accepted for presentation at the European Academy of Allergy and Clinical Immunology (EAACI) Congress 2024. The congress will be held in Valencia, Spain, from May 31 through June 3, 2024.
At this major European event, KalVista will highlight new data on sebetralstat, its oral on-demand treatment for hereditary angioedema (HAE). Key presentations include late-breaking results from the phase 3 KONFIDENT and KONFIDENT-S trials, as well as real-world data addressing delays in injectable treatment during HAE attacks. In addition, a dedicated symposium titled “Closing Gaps in HAE Management: Addressing Delays in On-Demand Treatment” will feature experts discussing patient care challenges and potential solutions.
This participation underscores KalVista’s commitment to advancing treatment options and improving the quality of life for patients with HAE. Congress attendees are encouraged to attend and engage with these timely findings.
Read Announcement
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