FDA Approves Second Indication for Brexafemme

The FDA has approved a second indication Brexafemme (ibrexafungerp) to reduce the incidence of recurrent vulvovaginal candidiasis (VVC). Developed by Scynexis, Brexafemme is an oral triterpenoid antifungal that FDA approved to treat vulvovaginal candidiasis in June 2021. The therapy represents a new antifungal class in more 20 years and is the only treatment for vaginal yeast infections that is both oral and non-azole. It has broad activity on a range of Candida species, including azole-resistant strains.

Current treatments, including the oral Diflucan (fluconazole), for vaginal yeast infection are azole antifungals. About 7% of all Candida blood samples tested at the Centers for Disease Control and Prevention are resistant to fluconazole. Resistance is most common with Candida auris, Candida glabrata, and Candida parapsilosis.

“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,” David Angulo, M.D., chief medical officer of Scynexis, said in a press release.

The approval is based on positive results from the pivotal phase 3 CANDLE study that evaluated the safety and efficacy of monthly dosing of Brexafemme to reduce the incidence of recurrent vulvovaginal candidiasis. Results showed that 65.4% of patients receiving the treatment achieved clinical success by having no recurrence at all through week 24 compared with 53.1% of placebo-treated patients. The advantage of Brexafemme over placebo was sustained over the three-month follow-up period and remained statistically significant. In the study, Brexafemme 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.

The average retail price is $596.26 for four tablets, according to GoodRx. Brexafemme received coverage from a major national PBM representing 21 million commercially covered lives in October 2022, according a company presentation.