FDA Expands Ibrexafungerp Approval for Reduction of Recurrent Yeast Infection

The US Food and Drug Administration (FDA) has approved a second indication of ibrexafungerp for recurrent vulvovaginal candidiasis (VVC). Ibrexafungerp is the first and only FDA-approved antifungal to both treat vulvovaginal candidiasis (VVC) and prevent recurrent VVC.

The approval comes on the PDUFA date for non-azole oral ibrexafungerp tablets, which are marketed under the commercial name Brexafemme. Ibrexafungerp is a triterpenoid antifungal in late-stage development by the biotechnology company Scynexis.

“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.

This second FDA indication comes after a reviewal of phase 3 data from the CANDLE study that evaluated the safety and efficacy of monthly ibrexafungerp dosing to reduce the recurrence of yeast infection. Trial results demonstrated 65.4% of patients receiving ibrexafungerp had no VVC recurrences, whether culture-proven, presumed, of suspected, through study week 24. Comparatively, 53.1% of placebo recipients had no recurrences.

Through glucan synthase inhibition, ibrexafungerp is fungicidal against Candida species and kills its cells. The investigators noted that ibrexafungerp remained statistically more beneficial than placebo throughout the 3-month follow-up period.

The recommended dosage of ibrexafungerp for VVC is 2 150 mg tablets administered approximately 12 hours apart for 1 day, with a total dosage of 4 150 mg tablets. To reduce the recurrence of VVC, adult and postmenarchal women should continue with this dosing regimen once a month for 6 months. Ibrexafungerp may be taken with or without food.

The most common adverse events reported in ibrexafungerp clinical trials for VVC were diarrhea, nausea, abdominal pain, dizziness, and vomiting. During the ibrexafungerp trials for recurrent VVC, the most common side effects were headache, abdominal pain, diarrhea, nausea, urinary tract infection, and fatigue.

Notably, Scynexis recently shared plans to pivot its strategy and refocus ibrexafungerp development for hospital-based patients with severe, life-threatening infections. “We believe there is great potential in this area,” said Taglietti.

The company separately announced yesterday that a $3 million National Institutes of Health (NIH) grant was awarded to Case Western Reserve University researchers studying a second-generation fungerp, SCY-247.

“It is thrilling to see the NIH fund this important research to investigate oral and IV SCY-247, one of our patented triterpenoid antifungals, to target drug resistant C auris, where there is great need due to limited treatment options and the potential to save lives,” said Taglietti commented.