Filing Imminent As Mycovia’s Antifungal Prevents Recurrent Vulvovaginal Candidiasis

Private Company Is Preparing For Commercialization, Talking To Partners

Oteseconazole prevented recurrent VVC in two Phase III studies but Phase III data in acute treatment of VVC episodes in women with RVVC, also due this month, are needed to file for US FDA approval in the first half of 2021.

Oteseconazole prevented recurrent vulvovaginal candidiasis in more than 90% of women in the VIOLET studies • Source: Shutterstock

Mycovia Pharmaceuticals, Inc.’s oteseconazole prevented recurrent vulvovaginal candidiasis (RVVC) infections in almost all of the women treated with the oral antifungal drug in two Phase III clinical trials. Results from a third Phase III trial in the treatment of acute VVC infection in women with RVVC are expected this month and all three studies will support a filing with the US Food and Drug Administration during the first half of 2021.

Durham, NC-based Mycovia is a private company formed after NovaQuest Capital Management acquired Viamet Pharmaceuticals Holdings, LLC in 2018. CEO Patrick Jordan told Scrip that with backing from NovaQuest the company is preparing to commercialize oteseconazole on its own in the US

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