Mycovia Pharmaceuticals Submits New Drug Application to the U.S. FDA for Oteseconazole for the Treatment of Recurrent Vulvovaginal Candidiasis
– NDA supported by positive data from VIOLET and ultraVIOLET Phase 3 clinical trials evaluating oteseconazole in more than 870 women in 11 countries –
– Oteseconazole’s Qualified Infectious Disease Product and Fast-Track designations allow for six month priority review by FDA following its acceptance of the NDA –
Durham, N.C. – June 1, 2021 – Mycovia Pharmaceuticals, Inc. (“Mycovia”), an emerging biopharmaceutical company dedicated to recognizing and empowering those living with unmet medical needs by developing novel therapies, today announced it has submitted its New Drug Application (NDA) for oteseconazole, an oral antifungal product for the treatment of recurrent vulvovaginal candidiasis (RVVC). Also known as chronic yeast infection, RVVC is a debilitating infectious condition defined as three or more episodes per year. Although RVVC affects nearly 138 million women worldwide each year and 6 million women in the U.S. alone, there are currently no FDA-approved treatments.