1 December 2022 - Approval is based on pivotal Phase 3 CANDLE data demonstrating statistically significant superiority of ibrexafungerp over placebo for primary and key secondary outcomes.
Scynexis today announced that the US FDA has approved a second indication for Brexafemme (ibrexafungerp) for the reduction in the incidence of recurrent vulvovaginal candidiasis.