SCYNEXIS has announced that the FDA has accepted the submission for their ibrexafungerp tablets BREXAFEMME.
SCYNEXIS’s submission has been granted priority review and given a target regulatory decision date of November 30, 2022. SCYNEXIS submitted this New Drug Application to expand the label of BREXAFEMME to include the prevention of recurrent vulvovaginal candidiasis.
Mycovia Pharmaceuticals received approval from the FDA for medication to treat RVVC back in May of 2022; however, if approved for this second indication, BREXAFEMME would be the first therapy approved for both treatment of vulvovaginal candidiasis (VVC) and the prevention of recurrent VVC.
“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 their CANDLE study results at the Infectious Diseases Society for Obstetrics and Gynecology (IDSOG) Annual Meeting being held in Boston on August 4-6, 2022.