FDA Approves Brexafemme for Recurrent Vulvovaginal Candidiasis
Brexafemme is an oral antifungal agent representing a novel therapeutic class of structurally-distinct glucan synthase inhibitors known as triterpenoids.
Brexafemme is an oral antifungal agent representing a novel therapeutic class of structurally-distinct glucan synthase inhibitors known as triterpenoids.
The sNDA is supported by data from the phase 3 CANDLE study.
The overall safety findings of Solosec in pediatric patients were consistent with those observed in adult patients.
The product is designed as a one-time vaginally administered treatment.
The NDA submission is supported by data from three phase 3 trials, which included 2 global studies and one US-focused study.