FDA approves ibrexafungerp for reduction in the incidence of RVVC

The US Food and Drug Administration (FDA) has approved ibrexafungerp (Brexafemme; Scynexis) for the reduction in the incidence of recurrent vulvovaginal candidiasis (RVVC), otherwise known as chronic yeast infections.¹

Now, ibrexafungerp is approved for the treatment of vulvovaginal candidiasis and the reduction in the incidence of RVVC.

“We are proud to be continuous innovators in the anti-infective space, and to provide a groundbreaking antifungal treatment option proven to reduce recurrence in women suffering from repeated vaginal yeast infections,” said Marco Taglietti, MD, president and CEO of Scynexis.

He added, “Brexafemme was already the only non-azole oral therapy available for VVC and is now the only therapy FDA-approved for both VVC and RVVC. This exciting second indication supports our mission to arm both patients and healthcare providers with innovative solutions in the fight against severe fungal infections.”

The approval was based on positive data from the phase 3 CANDLE study investigating the efficacy and safety of monthly dosing of ibrexafungerp to reduce the incidence 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.

The non-azole medication was also generally well-tolerated and safe, with the most reported adverse events being headaches or gastrointestinal-related (ie, diarrhea, nausea). Adverse events were also generally consistent with the previous Brexafemme label.

“Brexafemme, which has the ability to kill the infection-causing fungi, also can reduce the incidence of VVC episodes, benefiting many patients who have repeated infections and inadequate treatment options,” said David Angulo, MD, chief medical officer of Scynexis. “We thank all the clinical investigators and patients who participated in our CANDLE study who made this achievement possible.”

Reference:

1. SCYNEXIS Announces FDA Approval of Second Indication for BREXAFEMME (ibrexafungerp tablets) for Reduction in Incidence of Recurrent Vulvovaginal Candidiasis. SCYNEXIS. December 1, 2022. Accessed December 1, 2022. https://www.scynexis.com/news-media/press-releases/detail/314/scynexis-announces-fda-approval-of-second-indication-for