Posted by Michael Wonder on 09 Jun 2022
Scynexis announces submission of supplemental new drug application of Brexafemme (ibrexafungerp tablets) to the U.S. FDA for an expanded indication for the prevention of recurrent vaginal yeast infection
8 June 2022 - Regulatory submission for the label extension is supported by positive data from the pivotal Phase 3 CANDLE trial in which ibrexafungerp successfully achieved statistically significant superiority over placebo for the primary and key secondary study outcomes.
Scynexis today announced the submission of a supplemental new drug application to the U.S. FDA of an additional indication for Brexafemme (ibrexafungerp tablets) for the prevention of recurrent vulvovaginal candidiasis.
