This section highlights FDA-related milestones and regulatory updates for drugs developed by TFF Pharmaceuticals (TFFP).
Over the past two years, TFF Pharmaceuticals has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
Tacrolimus and TFF-dry. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Tacrolimus Inhalation Powder - FDA Regulatory Timeline and Events
Tacrolimus Inhalation Powder is a drug developed by TFF Pharmaceuticals for the following indication: Lung transplant.
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:
- Tacrolimus Inhalation Powder
- Announced Date:
- August 6, 2024
- Indication:
- Lung transplant
Announcement
TFF Pharmaceuticals, provided an update from the Company's ongoing Phase 2 trial of Tacrolimus Inhalation Powder (TFF TAC) for the prevention of lung transplant rejection.
AI Summary
TFF Pharmaceuticals announced exciting progress in its ongoing Phase 2 trial of Tacrolimus Inhalation Powder (TFF TAC) for preventing lung transplant rejection. The recent update shows that patient enrollment has accelerated, with 13 patients now participating. The trial results indicate that using approximately 20% of the oral tacrolimus dose prevented acute rejection while achieving over 80% of the blood levels seen with the oral formulation. This lower dose reduces the overall drug burden and minimizes side effects.
Further, all 9 patients who completed the 12-week period chose to continue treatment with TFF TAC in the long-term extension phase, with several patients having received treatment for more than 6 months. The study also noted a 6.5-fold reduction in abnormally expressed rejection-related genes and no development of donor-specific antibodies, suggesting that TFF TAC provides effective systemic immunosuppression. The company is finalizing the next study design and plans to give a regulatory update in the fall.
Read Announcement- Drug:
- Tacrolimus Inhalation Powder
- Announced Date:
- May 15, 2024
- Indication:
- Lung transplant
Announcement
TFF Pharmaceuticals, provided an update from the Company's ongoing Phase 2 trial of Tacrolimus Inhalation Powder (TFF TAC) for the prevention of lung transplant rejection.
AI Summary
TFF Pharmaceuticals recently provided an update on its ongoing Phase 2 trial investigating Tacrolimus Inhalation Powder (TFF TAC) for the prevention of lung transplant rejection. The trial aims to evaluate whether the inhaled formulation can offer an effective and targeted alternative to traditional systemic immunosuppressive treatments. By delivering the drug directly to the lungs, the company hopes to reduce overall side effects and improve patient outcomes by concentrating the therapeutic effects where they are most needed.
The update highlighted that early observations from the trial are important in understanding both the safety profile and the efficacy of TFF TAC. These insights could guide future treatment strategies for lung transplant recipients, potentially offering a new approach in managing transplant rejection risks. As the study continues, TFF Pharmaceuticals remains committed to advancing care for lung transplant patients with innovative, targeted therapies.
Read Announcement- Drug:
- Tacrolimus Inhalation Powder
- Announced Date:
- April 29, 2024
- Indication:
- Lung transplant
Announcement
TFF Pharmaceuticals, announced that data from the Company's ongoing Phase 2 trial of Tacrolimus Inhalation Powder (TFF TAC) for the prevention of lung transplant rejection is available on the Company's website.
AI Summary
TFF Pharmaceuticals recently announced that data from its ongoing Phase 2 trial for Tacrolimus Inhalation Powder (TFF TAC) to prevent lung transplant rejection is now available on the company’s website following an 8-K filing. The study findings show that TFF TAC can prevent lung transplant rejection at only one-sixth the oral dose and with lower systemic exposure. These results suggest that TFF TAC can deliver effective immune suppression while minimizing systemic side effects.
The data, presented by Professor Gregory Snell at the International Society for Heart and Lung Transplantation 44th Annual Meeting, underscores the potential of TFF TAC to improve the standard of care for lung transplant patients. The positive feedback from the transplant medicine community has increased enthusiasm for moving the program toward registrational testing in the near future.
Read Announcement- Drug:
- Tacrolimus Inhalation Powder
- Announced Date:
- April 15, 2024
- Indication:
- Lung transplant
Announcement
TFF Pharmaceuticals, announced additional positive data from the ongoing Phase 2 study which is evaluating Tacrolimus Inhalation Powder (TFF TAC) for the prevention of organ rejection in lung transplant recipients.
AI Summary
TFF Pharmaceuticals has announced positive new data from its ongoing Phase 2 study of Tacrolimus Inhalation Powder (TFF TAC) for preventing organ rejection in lung transplant recipients. The study, presented at the International Society for Heart and Lung Transplantation 44th Annual Meeting, showed that patients switching from oral tacrolimus to TFF TAC experienced normalization of rejection-related genes. This suggests that the inhaled treatment provides effective local immunosuppression in the lung at only one-sixth of the oral dose, with systemic exposure at about two-thirds of the level seen with oral administration. Such lower systemic levels may help decrease kidney toxicity while supporting adequate immune suppression. Moreover, all four patients with available gene expression data showed no signs of rejection, and every patient who completed the initial 12-week period chose to continue into the study’s safety extension phase.
Read Announcement
TFF-dry powder HA - FDA Regulatory Timeline and Events
TFF-dry powder HA is a drug developed by TFF Pharmaceuticals for the following indication: Bivalent Universal Influenza Vaccine.
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:
- TFF-dry powder HA
- Announced Date:
- September 10, 2024
- Indication:
- Bivalent Universal Influenza Vaccine
Announcement
TFF Pharmaceuticals, announces positive preclinical data advancing a multivalent universal influenza vaccine manufactured by TFF to protect against seasonal and pandemic viruses.
AI Summary
TFF Pharmaceuticals has announced encouraging preclinical data for its multivalent universal influenza vaccine, developed using its patented Thin Film Freezing (TFF) technology. The novel vaccine candidate, designed as a dry powder for intranasal delivery, was tested in ferrets and produced neutralizing antibody titers against both H1 and H3 influenza strains. Researchers, in collaboration with the Cleveland Clinic, observed that the vaccine triggered strong immune responses, suggesting it could protect against a wide range of seasonal and pandemic influenza viruses. The vaccine’s formulation is shelf-stable and may be self-administered, making it a promising candidate for broader protection irrespective of the flu strain in circulation. These positive findings support the continued development of a universal influenza vaccine that could potentially guard against more than 75% of circulating strains.
Read Announcement
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