WebBREXAFEMME, an oral, non-azole medication, is the first and only FDA-approved therapy for both the treatment of vulvovaginal candidiasis (VVC) and the reduction in the incidence of recurrent VVC. ... The approval is … WebBREXAFEMME has a differentiated fungicidal mechanism of action that kills a broad range of Candida species, including azole-resistant strains. We are working on completing our …
U.S. FDA Approves Brexafemme for VVC – PharmaLive
WebJun 2, 2024 · The company said it is working on completing its CANDLE study investigating ibrexafungerp for the prevention of recurrent VVC and expect we will be submitting a supplemental NDA in the first half ... WebApr 10, 2024 · SCYNEXIS Announces Positive Results from Its Pivotal Phase 3 CANDLE Study of Oral Ibrexafungerp for Prevention of Recurrent Vaginal Yeast Infections Feb 11. ... It offers BREXAFEMME for the treatment of vulvovaginal candidiasis (VVC) and recurrent VVC. The company’s lead product candidate is Ibrexafungerp, an intravenous drug for … story layout plan
FDA Approves Brexafemme for Recurrent Vulvovaginal Candidiasis
WebDec 2, 2024 · The approval is based on positive results from the pivotal phase 3 CANDLE study that evaluated the safety and efficacy of monthly dosing of Brexafemme to reduce the incidence of recurrent vulvovaginal … WebDec 1, 2024 · BREXAFEMME, an oral, non-azole medication, is the first and only FDA-approved therapy for both the treatment of vulvovaginal candidiasis (VVC) and the reduction in the incidence of recurrent VVC. Web“We thank all the clinical investigators and patients who participated in our CANDLE study who made this achievement possible.” Brexafemme is now available to appropriate patients for both the VVC and RVVC indications, while the Company pursues a U.S. commercialization partner to maximize the drug’s promotional reach and commercial value. story layout template