FDA approves second indication for ibrexafungerp in recurrent vulvovaginal candidiasis

The FDA approved ibrexafungerp, an oral, non-azole antifungal drug, for reducing the number of recurrent vulvovaginal candidiasis incidences, according to a press release.

This is the second indication for ibrexafungerp (Brexafemme, Scynexis), which was initially approved for the treatment of vulvovaginal candidiasis in June 2021.

The approval was based on results from the phase 3 CANDLE study announced earlier this year. Through week 24 of the trial, participants assigned ibrexafungerp were more likely to experience no recurrence of vulvovaginal candidiasis compared with those taking placebo (65.4% vs. 53.1%).

“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,” Marco Taglietti, MD, president and CEO of Scynexis, said in the release. “Brexafemme was already the only non-azole oral therapy available for vulvovaginal candidiasis and is now the only therapy FDA-approved for both vulvovaginal candidiasis and recurrent vulvovaginal candidiasis. This exciting second indication supports our mission to arm both patients and health care providers with innovative solutions in the fight against severe fungal infections.”

The recommended dosage for reducing incidence of recurrent vulvovaginal candidiasis is 600 mg per day of ibrexafungerp for 1 day each month, according to the release.