Scynexis, Inc. is poised to add a valuable second indication to labeling for its novel, first-in-class antifungal Brexafemme, announcing on 10 February that the oral triterpenoid met the primary endpoint in a 260-patient Phase III study in recurrent vaginal yeast infections, also known as vulvovaginal candidiasis. The company intends to submit a supplemental new drug application for rVVC during the first half of 2022, CEO Marco Taglietti told a same-day investor call.
Brexafemme (ibrexafungerp) obtained US Food and Drug Administration approval in June 2021 for treatment of vaginal yeast infections caused by pathogenic Candida infections, but the rVVC indication could offer a considerable market opportunity as well as the first US drug approval for prevention of vaginal yeast infections. (Also see "Scynexis Will Use Contract Commercial Firm To Market Novel Antifungal" - Scrip, 2 June, 2021
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