Atea Pharmaceuticals announced that the United States Food and Drug Administration, FDA, has granted Fast Track designation, FTD, to bemnifosbuvir for the treatment of COVID-19. Bemnifosbuvir is an oral, direct-acting antiviral drug candidate being evaluated in the global Phase 3 SUNRISE-3 registrational trial for the treatment of COVID-19 in outpatients at high risk for disease progression regardless of vaccination status. "The decision to grant FTD by the FDA for bemnifosbuvir reflects the continuing unmet medical need that remains for COVID-19 patients. FTD has the potential to expedite the development of bemnifosbuvir and we look forward to ongoing discussions with the FDA," said Jean-Pierre Sommadossi, PhD, Chief Executive Officer and Founder of Atea Pharmaceuticals. "Due to the limitations of current antiviral treatments, including drug-drug interactions and potential risks for genotoxicity and reproductive toxicity, as well as the ability of the virus to evade vaccines and monoclonal antibodies, new treatment options are urgently needed. In SUNRISE-3, we are targeting the most vulnerable patient populations who are at the greatest risk for disease progression to severe COVID-19 or mortality, and for whom there are currently the fewest treatment options."
Published first on TheFly
See today’s best-performing stocks on TipRanks >>
Read More on AVIR:
- Atea Pharmaceuticals Announces U.S. FDA Fast Track Designation Granted to Bemnifosbuvir, an Investigational Oral Antiviral, for the Treatment of COVID-19
- Atea Announces Presentation of Bemnifosbuvir Data Demonstrating Reduced Hospitalizations for COVID-19 Patients at 2023 European Congress of Clinical Microbiology & Infectious Diseases
- Atea Pharmaceuticals presents results from MORNINGSKY Phase 3 trial
- Atea announces presentation of Phase 1 data of bemnifosbuvir at ICAR 2023
- New Data Showcasing Favorable Profile of Bemnifosbuvir for Treatment of COVID-19 and Hepatitis C Presented at 2023 International Conference on Antiviral Research