Search jobs 01-Jun-2021 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. (BUSINESS WIRE) 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 inf
by WRAL TechWire June 1, 2021 .
DURHAM – Mycovia Pharmaceuticals has submitted its New Drug Application (NDA) to the United States Food and Drug Administration (FDA) for oteseconazole, an oral antifungal product for the treatment of chronic yeast infection, called recurrent vulvovaginal candidiasis (RVVC), described as three or more episodes per year in a patient, which affects nearly 138 million women globally each year.
The therapy developed by Mycovia was designed to be highly selective for its pathogenic target, the company said, which could result in fewer side effects and enhanced effectiveness compared to other treatment options available.
The company’s clinical development plan included three trials, two global VIOLET studies and one U.S.-focused ultraVIOLET study, including more than 870 patients at 232 sites across 11 countries.