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.
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Working with US FDA was key to developing clinical trials in the absence of regulatory precedents in recurrent vulvovaginal candidiasis, Scynexis VP tells the Pink Sheet; exposure profiles drove different trial designs for Scynexis’ Brexafemme and Mycovia’s just-launched Vivjoa.
Phase III data showed that the first-in-class oral antifungal can prevent recurrence of vaginal yeast infections, a potentially valuable label addition to the current indication for acute treatment.
The first-in-class, novel antifungal for vaginal yeast infections will enter a genericized market, but also one with strong demand for better therapeutic options.