Scynexis submits sNDA for expanded indication of ibrexafungerp tablets

Scynexis announced the submission of a supplemental New Drug Application (sNDA) to the US Food and Drug Administration (FDA) for ibrexafungerp tablets (Brexafemme; Scynexis) for the prevention of recurrent vulvovaginal candidiasis (RVVC).¹ 

Ibrexafungerp, a novel antifungal, was approved by the FDA in June 2021 for the treatment of vulvovaginal candidiasis (VVC), making it the first and only oral fungicidal treatment for VVC in adults and postmenarchal pediatric patients.¹

If the sNDA is approved, ibrexafungerp tablets would be the first and only oral non-azole medication for the prevention of RVVC, which is described as 3 or more occurrences of VVC in the past 12 months.

“This is an exciting and very important step in our efforts to bring our innovative, potent antifungal to market as a new alternative for women who suffer from recurring yeast infections,” said Marco Taglietti, MD, president and CEO of Scynexis. “As the only non-azole oral therapy available for VVC, Brexafemme is already revolutionizing how yeast infections are treated. Now, based on our pivotal CANDLE trial for RVVC, we see that ibrexafungerp, which can kill the yeast causing the infection, has shown it also can prevent recurrences of the disease and help patients who have failed to respond to multiple doses of fluconazole. We are thrilled about this advancement, which takes us one step closer to our vision of addressing this significant unmet need in women’s health.”

The recent submission 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.

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.

The FDA has designated Ibrexafungerp as a qualified infectious disease product (QIDP). This allows for a 6-month priority review and potential regulatory approval is expected by the end of 2022, according to a Scynexis press release.

Reference

1. SCYNEXIS Announces Submission of Supplemental New Drug Application of BREXAFEMME (ibrexafungerp tablets) to the U.S. Food and Drug Administration for an Expanded Indication for the Prevention of Recurrent Vaginal Yeast Infections. Scynexis. Published June 8, 2022. Accessed June 8, 2022. https://ir.scynexis.com/press-releases/detail/293/scynexis-announces-submission-of-supplemental-new-drug