WebAug 1, 2024 · The company will present CANDLE study results in the current week at the Infectious Diseases Society for Obstetrics and Gynecology (IDSOG) Annual Meeting. ... Annual Meeting. BREXAFEMME is an oral ... WebFeb 10, 2024 · The study comprised of 260 women who were experiencing RVVC, which is defined as 3 or more per year. All patients were given a 3-day regimen of open-label …
SCYNEXIS Announces FDA Approval of Second Indication …
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 … earning estimates
SCYNEXIS Announces FDA Approval of Second Indication for BREXAFEMME …
WebDec 1, 2024 · The US Food and Drug Administration (FDA) has approved a second indication of ibrexafungerp for recurrent vulvovaginal candidiasis (VVC). Ibrexafungerp is the first and only FDA-approved antifungal to both treat vulvovaginal candidiasis (VVC) and prevent recurrent VVC.. The approval comes on the PDUFA date for non-azole oral … WebMay 11, 2024 · In the study, ibrexafungerp was generally safe and well-tolerated with findings consistent with the existing Brexafemme (ibrexafungerp tablets) label. Earlier this year, Scynexis also announced positive results from its global Phase III CANDLE study investigating the safety and efficacy of oral ibrexafungerp for prevention of recurrent ... 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. Approval is based on pivotal Phase 3 CANDLE data demonstrating statistically significant superiority of ibrexafungerp over placebo for … cswh-gw201p-lf