Scynexis’ Phase III Success Brings New Antifungal Class Closer To Approval
Biotech plans to file its first-in-class triterpenoid agent for approval in 2020 following a second Phase III study in acute vulvovaginal candidiasis. Beyond that, it hopes for a supplemental approval in recurrent VVC.
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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.
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.
Novel antifungal ibrexafungerp, a first-in-class triterpenoid, demonstrates ability to clear vulvovaginal candidiasis infections in second pivotal study; firm also looks to demonstrate efficacy in recurrent infections.