This section highlights FDA-related milestones and regulatory updates for drugs developed by Aurinia Pharmaceuticals (AUPH).
Over the past two years, Aurinia Pharmaceuticals has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
AUR and LUPKYNIS. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
AUR 200 - FDA Regulatory Timeline and Events
AUR 200 is a drug developed by Aurinia Pharmaceuticals for the following indication: For B-cell mediated autoimmune diseases.
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:
- AUR 200
- Announced Date:
- June 29, 2025
- Indication:
- For B-cell mediated autoimmune diseases.
Announcement
Aurinia Pharmaceuticals Inc announced that it will host a webcast and conference call on June 30, 2025, at 8:30 a.m. ET to discuss AUR200 Phase 1 study results.
AI Summary
Aurinia Pharmaceuticals Inc. announced that it will host a webcast and conference call on June 30, 2025, at 8:30 a.m. ET to discuss the promising AUR200 Phase 1 study results. The webcast will provide detailed insights into the early clinical results of AUR200, a dual inhibitor targeting BAFF and APRIL, which is being developed as a potential treatment for autoimmune diseases. Participants can join the webcast via a link on Aurinia’s website, and the conference call is accessible by dialing 877-407-9170 or +1 201-493-6756. International callers have additional toll-free numbers available for access. A replay of the webcast will also be posted on the company's website, ensuring that anyone interested in learning more about the study outcomes and Aurinia’s innovative research will have the opportunity to review the information at their convenience.
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LUPKYNIS (voclosporin) - FDA Regulatory Timeline and Events
LUPKYNIS (voclosporin) is a drug developed by Aurinia Pharmaceuticals for the following indication: Lupus Nephritis.
This drug is approved by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- LUPKYNIS (voclosporin)
- Announced Date:
- May 22, 2025
- Indication:
- Lupus Nephritis
Announcement
Aurinia Pharmaceuticals Inc. announced that a post-hoc analysis of the 52-week, Phase 3 AURORA 1 study showed that lupus nephritis (LN) patients who received triple immunosuppressive therapy with LUPKYNIS® (voclosporin), mycophenolate mofetil (MMF), and low-dose glucocorticoids achieved lower proteinuria targets at substantially higher rates compared to patients in the control group who received mycophenolate mofetil (MMF) and low-dose glucocorticoids alone.
AI Summary
Aurinia Pharmaceuticals announced a post-hoc analysis from the 52‐week Phase 3 AURORA 1 study showing that lupus nephritis patients benefit from a triple immunosuppressive therapy. Patients who received LUPKYNIS® (voclosporin) along with mycophenolate mofetil (MMF) and low‐dose glucocorticoids were much more likely to reach low proteinuria targets compared to those receiving only MMF and low‐dose glucocorticoids. In the study, 60.9% of patients in the triple therapy group reached a urine protein creatine ratio (UPCR) of ≤0.4 g/g at least once, compared to 37.1% in the control group. This finding suggests that adding LUPKYNIS to the treatment regimen significantly lowers protein levels in the urine, a key goal for protecting kidney health in lupus nephritis. The results underline the potential of this combined therapy to offer improved kidney protection by achieving lower proteinuria targets more effectively.
Read Announcement- Drug:
- LUPKYNIS (voclosporin)
- Announced Date:
- November 15, 2024
- Indication:
- Lupus Nephritis
Announcement
Aurinia Pharmaceuticals Inc announced the acceptance of four poster presentations at the annual American College of Rheumatology Convergence (ACR) 2024 taking place in Washington, D.C., November 14-19.
AI Summary
Aurinia Pharmaceuticals recently announced that it will present four poster presentations at the American College of Rheumatology Convergence (ACR) 2024 in Washington, D.C., from November 14-19. These posters will highlight key clinical data on lupus nephritis—a serious complication of systemic lupus erythematosus—and discuss the importance of additional screening for early detection. The presentations will emphasize how routine kidney screenings are critical for better outcomes and will detail findings related to LUPKYNIS® (voclosporin), a second-generation calcineurin inhibitor shown to improve renal responses in patients with active lupus nephritis.
The studies set to be featured underline the pivotal role of rheumatologists in diagnosing and managing lupus nephritis. By sharing real-world evidence and clinical experiences, Aurinia aims to reinforce the need for proactive patient care and showcase innovative treatment strategies that can help minimize irreversible kidney damage.
Read Announcement- Drug:
- LUPKYNIS (voclosporin)
- Announced Date:
- October 11, 2024
- Indication:
- Lupus Nephritis
Announcement
Aurinia Pharmaceuticals Inc announced the acceptance of six abstracts, including five poster presentations, at the American Society of Nephrology (ASN) Kidney Week 2024 taking place in San Diego, CA October 23-27.
AI Summary
Aurinia Pharmaceuticals announced that six abstracts, including five poster presentations, have been accepted for ASN Kidney Week 2024, held in San Diego, CA from October 23-27. The abstracts focus on data supporting the clinical importance of LUPKYNIS® (voclosporin) in treating adults with active lupus nephritis, a serious kidney condition linked to lupus.
These presentations include findings from the ENLIGHT-LN registry, a U.S.-based study tracking real-world treatment patterns, and research into LUPKYNIS’ unique ability to stabilize podocytes—cells crucial for kidney function. The data presented at this prestigious event aim to enhance understanding of the drug’s impact on kidney health, particularly for populations disproportionately affected by lupus. This acceptance underscores Aurinia’s commitment to advancing innovative treatment options for patients with lupus nephritis.
Read Announcement- Drug:
- LUPKYNIS (voclosporin)
- Announced Date:
- September 24, 2024
- Indication:
- Lupus Nephritis
Announcement
Aurinia Pharmaceuticals Inc announced that the Japanese Ministry of Health, Labour, and Welfare has approved voclosporin, a second-generation calcineurin inhibitor, in combination with mycophenolate mofetil (MMF) to treat lupus nephritis (LN).
AI Summary
Aurinia Pharmaceuticals Inc. announced that the Japanese Ministry of Health, Labour, and Welfare has approved voclosporin, a second-generation calcineurin inhibitor, in combination with mycophenolate mofetil (MMF) for the treatment of lupus nephritis (LN). This decision follows a new drug application filed by its partner, Otsuka Pharmaceutical, in November 2023. The approval was based on results from the AURORA Clinical Program, which included a 12‐month Phase 3 study and a two-year extension study. These studies assessed the efficacy and safety of using voclosporin with MMF and low-dose glucocorticoids compared to standard treatment without voclosporin.
The milestone is significant for Japanese patients, where lupus nephritis is prevalent, as it provides a new treatment option to address a critical unmet medical need. This achievement underscores the strong collaboration between Aurinia and Otsuka to bring innovative therapies to markets with high demand.
Read Announcement- Drug:
- LUPKYNIS (voclosporin)
- Announced Date:
- June 5, 2024
- Indication:
- Lupus Nephritis
Announcement
Aurinia Pharmaceuticals Inc announced an oral presentation at the European Alliance of Associations for Rheumatology (EULAR) 2024 taking place in Vienna, Austria June 12-15.
AI Summary
Aurinia Pharmaceuticals announced that it will deliver an oral presentation at the European Alliance of Associations for Rheumatology (EULAR) 2024 conference in Vienna, Austria, from June 12 to 15. The presentation will feature new data from the AURORA Clinical Program, reinforcing earlier findings on LUPKYNIS® (voclosporin). The data highlights the benefits of a triple immunosuppressive regimen that includes LUPKYNIS alongside lower-dose mycophenolate mofetil (MMF) and low-dose steroids. This approach has been shown to achieve faster and greater reductions in proteinuria and significantly lower steroid exposure compared to traditional high-dose immunosuppressive therapy. The upcoming EULAR presentation is expected to provide important insights into the efficacy and safety of this innovative treatment strategy for adult patients with active lupus nephritis, potentially guiding initial therapy decisions in clinical practice.
Read Announcement - Drug:
- LUPKYNIS (voclosporin)
- Announced Date:
- May 14, 2024
- Indication:
- Lupus Nephritis
Announcement
Aurinia Pharmaceuticals Inc. announced the presentation of results from an updated cost-effective analysis of LUPKYNIS (voclosporin), a second generation calcineurin inhibitor (CNI), at the annual National Kidney Foundation (NKF) Spring Clinical Meeting 2024 taking place in Long Beach, CA, May 14-18. The Company will also share additional data from its AURORA clinical program.
AI Summary
Aurinia Pharmaceuticals Inc. announced that it will present updated results from a cost-effective analysis of its drug LUPKYNIS (voclosporin), a second-generation calcineurin inhibitor, at the National Kidney Foundation Spring Clinical Meeting 2024 in Long Beach, CA from May 14 to 18. This analysis aims to provide clearer insights into the economic value of LUPKYNIS, highlighting its potential benefits for healthcare providers and patients facing kidney-related conditions.
In addition to the cost-effectiveness data, Aurinia will share new information from its AURORA clinical program during the meeting. The additional data is expected to offer more details on the treatment’s performance and safety profile, which could help support better-informed decisions in kidney care. These presentations underscore the company’s commitment to advancing treatment options and providing valuable data to the medical community.
Read Announcement- Drug:
- LUPKYNIS (voclosporin)
- Announced Date:
- May 9, 2024
- Indication:
- Lupus Nephritis
Announcement
Aurinia Pharmaceuticals Inc announced the presentation of two studies at the annual Congress of Clinical Rheumatology (CCR) East 2024 taking place in Destin, FL, May 9-12
AI Summary
Aurinia Pharmaceuticals Inc. has announced that it will present two studies at the annual Congress of Clinical Rheumatology (CCR) East 2024. The event is scheduled to take place in Destin, Florida, from May 9-12, 2024. During this conference, the company will share important findings from its latest research, which aims to improve the understanding and treatment of rheumatic diseases. These studies are expected to provide valuable insights into new potential therapies and highlight promising treatment protocols for patients with autoimmune conditions.
The CCR East congress gathers healthcare professionals, researchers, and industry experts to discuss emerging trends and advancements in clinical rheumatology. Aurinia’s participation demonstrates its commitment to advancing patient care and contributing to innovative treatment solutions. The presentation of these studies is anticipated to spark further discussion and collaboration in the field of rheumatology research.
Read Announcement- Drug:
- LUPKYNIS (voclosporin)
- Announced Date:
- April 30, 2024
- Indication:
- Lupus Nephritis
Announcement
Aurinia Pharmaceuticals Inc announced that the FDA has approved a label update for LUPKYNIS.
AI Summary
The FDA has approved an important label update for LUPKYNIS by Aurinia Pharmaceuticals. The revised label now includes three-year data from the AURORA 2 extension study, demonstrating that patients with active lupus nephritis continue to maintain a sustained complete renal response when treated with LUPKYNIS, mycophenolate mofetil, and low-dose glucocorticoids. This update removes the previous language which stated that safety and efficacy had not been established beyond one year of treatment.
Additionally, the new label provides updated guidance on monitoring kidney function. Instead of assessing eGFR every four weeks indefinitely, physicians will now monitor kidney function every two weeks for the first month, then monthly during the first year, and quarterly after that. The safety profile remains unchanged and consistent with the findings from the AURORA clinical program.
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