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VT 1161 filed with FDA for vulvovaginal candidiasis.- Mycovia Pharmaceuticals

Read time: 1 mins
Published:2nd Jun 2021
Mycovia Pharmaceuticals has submitted its New Drug Application (NDA) for VT 1161 (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.Oteseconazole’s clinical development plan was comprised of three trials – two global VIOLET studies and one U.S.-focused ultraVIOLET study, including more than 870 patients at 232 sites across 11 countries. Both VIOLET studies met their primary and key secondary endpoints. Additionally, results from ultraVIOLET demonstrated oteseconazole’s effectiveness in treating acute episodes of VVC and reinforced its efficacy and safety profile in treating RVVC as compared to fluconazole. Combined Phase III data showed that oteseconazole protected more than 90% of participants from having a recurrence for nearly a year.

Condition: Vulvovaginal Candidiasis
Type: drug

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