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Atea Pharmaceuticals Announces U.S. FDA Fast Track Designation Granted to Bemnifosbuvir, an Investigational Oral Antiviral, for the Treatment of COVID-19
BOSTON, April 25, 2023 (GLOBE NEWSWIRE) -- Atea Pharmaceuticals, Inc. (Nasdaq: AVIR) (“Atea”), a clinical-stage biopharmaceutical company engaged in the
About this update from Atea Pharmaceuticals, Inc.
[{"type":"text","content":"BOSTON, April 25, 2023 (GLOBE NEWSWIRE) -- Atea Pharmaceuticals, Inc. (Nasdaq: AVIR) (“Atea”), a clinical-stage biopharmaceutical company engaged in the discovery and development of oral antiviral therapeutics for serious viral diseases, today 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. This includes patients over the age of 80, patients 65 years or older with at least one major risk factor, and anyone over the age of 18 who is immunocompromised. “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.” About Bemnifosbuvir Fast Track Designation The FDA’s Fast Track program is designed to facilitate the expedited development and review of new drugs or biologics that are intended to treat serious or life-threatening conditions and demonstrate the potential to address unmet medical needs. Among other things, as a result of the Fast Track designation, Atea may benefit from more frequent communications with the FDA to discuss the development plan of bemnifosbuvir for the treatment of COVID-19 and rolling review of any completed sections of any resulting New Drug Application (NDA). About the Phase 3 SUNRISE-3 Trial SUNRISE-3 is a randomized, double-blind, placebo-controlled, global Phase 3 trial d...