The decision makes Brexafemme, a novel oral antifungal, the first and only FDA-approved therapy for both the treatment of vulvovaginal candidiasis (VVC) – approved in June 2021 – and the reduction in the incidence of RVVC.
The company’s application was supported by positive results from the pivotal phase 3 CANDLE study evaluating the safety and efficacy of monthly dosing of Brexafemme to reduce the incidence of RVVC.
Results showed 65.4% of patients receiving Brexafemme 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.
