FDA grants ibrexafungerp sNDA priority review for RVVC
If approved, ibrexafungerp would be the first and only approved therapy for both the treatment of vulvovaginal candidiasis (VVC) and the prevention of recurrent vulvovaginal candidiasis (RVVC).
Scynexis announced the US Food and Drug Administration (FDA) has accepted the supplemental New Drug Application (sNDA) and granted priority review for the company’s ibrexafungerp tablets (Brexafemme) for the prevention of recurrent vulvovaginal candidiasis (RVVC).1
The drug is currently approved by the FDA for the treatment of vulvovaginal candidiasis (VVC) in adults and postmenarchal pediatric females, and if approved, ibrexafungerp would be the first and only approved therapy for the treatment of VVC, as well as the prevention of RVVC, according to a press release.1
The FDA has designated Ibrexafungerp as a qualified infectious disease product (QIDP), allowing for a 6-month priority review. The FDA set a November 30, 2022, PDUFA target date to decide on approval.
“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, MD, president and CEO 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.”
This priority review decision is based on positive data from the global phase 3 CANDLE study investigating the efficacy and safety of monthly dosing of ibrexafungerp for the prevention of RVVC.2
Results of the study demonstrated 65.4% of patients who received ibrexafungerp achieved clinical success-defined as having no recurrence at all, either culture-proven, presumed, or suspected through Week 24-vs 53.1% of placebo patients (p = 0.02).
Ibrexafungerp sustained an advantage over placebo and remained statistically significant throughout a 3-month follow-up period (p = 0.034). Additionally, ibrexafungerp was well-tolerated with commonly reported adverse events including headache, diarrhea, and nausea, which were generally mild and consistent with the medication’s current label.
This article was published by our sister publication Contemporary OB/GYN.
References
1. 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. SCYNEXIS. August 1, 2022. Accessed August 2, 2022. https://ir.scynexis.com/press-releases/detail/297/scynexis-announces-u-s-food-and-drug-administration
2. Petronelli M. Scynexis submits sNDA for expanded indication of ibrexafungerp tablets. Contemporary OB/GYN. June 8, 2022. Accessed July 21, 2022. https://www.contemporaryobgyn.net/view/scynexis-submits-snda-for-expanded-indication-of-ibrexafungerp-tablets
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