The US Food and Drug Administration (FDA) has approved a second indication for Scynexis’ Brexafemme (ibrexafungerp tablets) for the reduction in the incidence of recurrent vulvovaginal candidiasis (RVVC).
The decision makes Brexafemme, a novel oral antifungal, the first and only FDA-approved therapy for both the treatment of vulvovaginal candidiasis (VVC) – approved in June 2021 – and the reduction in the incidence of RVVC.
The company’s application was supported by positive results from the pivotal phase 3 CANDLE study evaluating the safety and efficacy of monthly dosing of Brexafemme to reduce the incidence of RVVC.
Results showed 65.4% of patients receiving Brexafemme 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.
This advantage of Brexafemme over placebo was sustained over the three-month follow-up period and remained statistically significant.
Brexafemme was generally safe and well-tolerated, the company said in a statement, with the most commonly reported adverse events generally mild and consistent with the previous Brexafemme label.
VVC is a common infection caused by Candida, a type of yeast that normally lives on skin and inside the body such as in the mouth, throat, gut and vagina. An estimated 75% of women will have at least one episode of VVC, and 40% to 45% will have two or more episodes.
Recurrent VVC, usually defined as three or more episodes of symptomatic VVC in under a year, affects less than 5% of women, but carries a substantial economic burden, according to the US Centers for Disease Control and Prevention.
“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, chief medical officer of Scynexis.
Also commenting on the FDA’s latest decision, Marco Taglietti, president and chief executive officer of Scynexis, said: “… This exciting second indication supports our mission to arm both patients and healthcare providers with innovative solutions in the fight against severe fungal infections.”