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 … WebAug 1, 2024 · SCYNEXIS will present CANDLE study results this week at the Infectious Diseases Society for Obstetrics and Gynecology (IDSOG) Annual Meeting being held in Boston August 4-6, 2024. Ibrexafungerp is designated by the FDA as a qualified infectious disease product (QIDP), allowing for a six-month priority review.
SCYNEXIS Presents Positive Data from Its Pivotal Phase 3 CANDLE …
WebMay 10, 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 3 CANDLE study investigating the safety and efficacy of oral ibrexafungerp for prevention of … 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 … orion tech fest
SCYNEXIS Announces FDA Approval of BREXAFEMME® …
WebAug 4, 2024 · Positive results from the CANDLE study were the basis of SCYNEXIS’s June 2024 sNDA submission to the U.S. Food and Drug Administration (FDA) for an additional … 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 CANDLE study investigating ibrexafungerp for the prevention of recurrent VVC and expect we will be submitting a supplemental NDA in the first half of 2024. 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 … how to write intervals in music