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SCYNEXIS’ Brexafemme (ibrexafungerp) Receives the US FDA’s Approval for Reduction in Incidence of Recurrent Vulvovaginal Candidiasis

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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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Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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