Vaginal Yeast Infections Are A Bright Spot For Anti-Infective Development
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.
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US FDA closed out the month of April with two new molecular entity approvals that address underserved markets but carry some safety concerns.
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.
Scynexis obtained US FDA approval of ibrexafungerp, from the first novel class of antifungals in 20 years, and plans to use a contractor for US marketing of Brexafemme for vaginal yeast infections caused by Candida fungi.