FDA Approves Second Indication for BREXAFEMME® for Reduction in Incidence of Recurrent Vulvovaginal Candidiasis
Posted on December 13, 2022
Source: SCYNEXIS
- BREXAFEMME, an oral, non-azole medication, is the first and only FDA-approved therapy for both the treatment of vulvovaginal candidiasis (VVC) and the reduction in the incidence of recurrent VVC.
- Approval is based on pivotal Phase 3 CANDLE data demonstrating statistically significant superiority of ibrexafungerp over placebo for primary and key secondary endpoints.
SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant fungal infections, today announced that the U.S. Food and Drug Administration (FDA) has approved a second indication for BREXAFEMME® (ibrexafungerp tablets) for the reduction in the incidence of recurrent vulvovaginal candidiasis (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, M.D., President and Chief Executive Officer of SCYNEXIS. “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 is based on positive results from the pivotal Phase 3 CANDLE study that evaluated the safety and efficacy of monthly dosing of ibrexafungerp to reduce the incidence of RVVC. Results showed that 65.4% of patients receiving ibrexafungerp achieved clinical success by having no recurrence at all, either culture-proven, presumed, or suspected, through Week 24 compared to 53.1% of placebo-treated patients (p=0.02). The advantage of ibrexafungerp over placebo was sustained over the three-month follow-up period and remained statistically significant (p=0.034). In the study, ibrexafungerp was generally safe and well-tolerated. The most commonly reported adverse events were headaches or were gastrointestinal in nature (i.e., diarrhea, nausea), and were mostly mild and 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, M.D., Chief Medical Officer of SCYNEXIS. “We thank all the clinical investigators and patients who participated in our CANDLE study who made this achievement possible.”
BREXAFEMME is now available to appropriate patients for both the VVC and RVVC indications, while the Company pursues a U.S. commercialization partner to maximize the drug’s promotional reach and commercial value.