Mycovia Pharmaceuticals Announces U.S. FDA Acceptance and Priority Review of New Drug Application for Oteseconazole for the Treatment of Recurrent Vulvovaginal Candidiasis
– Six-month priority review granted for oteseconazole with PDUFA target action date set for January 27, 2022 –
– NDA supported by positive data from VIOLET and ultraVIOLET Phase 3 clinical trials evaluating oteseconazole in more than 870 women with RVVC in 11 countries –
– Mycovia preparing for the U.S. launch of oteseconazole in early 2022 pending full FDA approval –
Durham, N.C. – July 28, 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 the U.S. Food and Drug Administration (FDA) has accepted for review 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 distinct condition from vulvovaginal candidiasis (VVC) and defined as three or more symptomatic acute episodes of yeast infection per year. 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.