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SCYNEXIS Announces U.S. Food and Drug Administration Acceptance and Priority Review of the Supplemental New Drug Application for BREXAFEMME® (ibrexafungerp tablets) for Prevention of Recurrent Vaginal Yeast Infections
Submission has been granted priority review and given a target regulatory decision date of November 30, 2022.If approved for this second indication,
About this update from Scynexis, Inc.
[{"type":"text","content":"Submission has been granted priority review and given a target regulatory decision date of November 30, 2022.If approved for this second indication, BREXAFEMME would be the first and only therapy approved in the U.S. for both the treatment of vulvovaginal candidiasis (VVC) and the prevention of recurrent VVC.Regulatory submission for the label extension is supported by positive data from the pivotal Phase 3 CANDLE study in which ibrexafungerp successfully achieved statistically significant superiority over placebo for the primary and key secondary study endpoints.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, 2022. JERSEY CITY, N.J., Aug. 01, 2022 (GLOBE NEWSWIRE) -- SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant infections, today announced that the U.S. Food and Drug Administration (FDA) has accepted the Company’s submission of a supplemental New Drug Application (sNDA) to expand the label of BREXAFEMME® (ibrexafungerp tablets) to include the prevention of recurrent vulvovaginal candidiasis (RVVC). The FDA granted the submission Priority Review and assigned the Prescription Drug User Fee Act (PDUFA) target decision date as November 30, 2022. If approved for this second indication, BREXAFEMME, an oral non-azole therapy, would be the first and only product approved in the U.S. for both the treatment of vulvovaginal candidiasis (VVC) and the prevention of RVVC, defined as three or more infections in a 12-month period. “The FDA’s acceptance of this submission is excellent news for patients, and it brings us another step closer to our vision of addressing significant unmet needs in women’s health,” said Marco Taglietti, M.D., President and Chief Executive Officer of SCYNEXIS. “Our pivotal CANDLE study was the basis of the sNDA submission, and we look forward to presenting details of these data to the medical community.” 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, 2022. Ibrexafungerp is designated by the FDA as a qualified infectious disease product (QIDP), allowing for a six-mont...