July 28, 2021 /Bio Valley BIOON/ --Mycovia Pharmaceuticals recently announced that the U.S. Food and Drug Administration (FDA) has accepted the new drug application (NDA) for oteseconazole (VT-1161) and granted priority review. Oteseconazole is an oral antifungal drug used to treat recurrent vulvovaginal candidiasis (RVVC).
The FDA has designated the NDA’s "Prescription Drug User Fees Act" (PDUFA) target action date of January 27, 2022. Previously, the FDA has granted oteseconazole Qualified Infectious Disease Product Designation (QIDP) and Fast Track Designation (FTD). According to this schedule, Mycovia plans to launch oteseconazole in the U.S. market in early 2022 after obtaining a full review and approval from the FDA.
RVVC, also known as chronic yeast infection, is a disease different from vulvovaginal candidiasis (VVC). It is defined as an acute attack of symptomatic yeast infection three or more times a year. The main symptoms include vaginal itching, burning, irritation and Inflammation. Some women may experience abnormal vaginal discharge, painful intercourse, or painful urination, causing various but often severe discomfort and pain. RVVC is a chronic infectious disease that affects nearly 138 million women worldwide each year, and there are 6 million women in the United States alone. Currently, there is no FDA-approved treatment for RVVC.
Oteseconazole (VT-1161) is an orally administered fungal CYP51 inhibitor developed by Mycovia for the treatment of RVVC and onychomycosis. Compared with currently available antifungal drugs, oteseconazole has higher selectivity, fewer side effects and higher efficacy.
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