Scynexis announces FDA approval of second indication for BREXAFEMME

SCYNEXIS announced that the U.S. Food and Drug Administration, FDA, has approved a second indication for BREXAFEMME for the reduction in the incidence of recurrent vulvovaginal candidiasis, RVVC. "We are proud to be continuous innovators in the anti-infective space, and to provide a groundbreaking antifungal treatment option proven to reduce recurrence in women suffering from repeated vaginal yeast infections," said Marco Taglietti, M.D., President and Chief Executive Officer of SCYNEXIS. "BREXAFEMME was already the only non-azole oral therapy available for VVC and is now the only therapy FDA-approved for both VVC and RVVC. This exciting second indication supports our mission to arm both patients and healthcare providers with innovative solutions in the fight against severe fungal infections." The approval is based on positive results from the pivotal Phase 3 CANDLE study that evaluated the safety and efficacy of monthly dosing of ibrexafungerp to reduce the incidence of RVVC. Results showed that 65.4% of patients receiving ibrexafungerp achieved clinical success by having no recurrence at all, either culture-proven, presumed, or suspected, through Week 24 compared to 53.1% of placebo-treated patients.