SCYNEXIS’ Brexafemme (ibrexafungerp) Receives the US FDA’s Approval for Reduction in Incidence of Recurrent Vulvovaginal Candidiasis
Shots:
- The US FDA has approved Brexafemme for the reduction in the incidence of recurrent vulvovaginal candidiasis
- The approval was based on the P-III (CANDLE) study evaluating the safety & efficacy of ibrexafungerp vs PBO showed that 65.4% vs 53.1% of patients treated with ibrexafungerp achieved clinical success with no recurrence either culture-proven, presumed, or suspected @24wk. The advantage was sustained over 3mos. follow-up period and remained statistically significant, was generally safe and well-tolerated
- The results were generally consistent with the prior Brexafemme label. Brexafemme is a novel oral antifungal that has been approved in the US in June 2021 for vulvovaginal candidiasis
Ref: Globenewswire | Image: SCYNEXIS
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