FDA approves ibrexafungerp tablet for recurrent vulvovaginal candidiasis

The Food and Drug Administration (FDA) has approved Brexafemme® (ibrexafungerp) for reducing incidence of recurrent vulvovaginal candidiasis (RVVC) in adult and postmenarchal pediatric females.

Brexafemme is an oral antifungal agent belonging to a novel therapeutic class of structurally-distinct glucan synthase inhibitors called triterpenoids. Brexafemme® has been shown to have broad spectrum antifungal activity against multidrug-resistant pathogens, including azole- and echinocandin-resistant strains.

"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.

About BREXAFEMME® (ibrexafungerp tablets)

BREXAFEMME is a novel oral antifungal approved in June 2021 by the U.S. Food and Drug Administration for the treatment of vulvovaginal candidiasis (VVC). BREXAFEMME received approval for a second indication on November 30, 2022, for reduction in the incidence of recurrent VVC. Its mechanism of action, glucan synthase inhibition, is fungicidal against Candida species, meaning it kills fungal cells. BREXAFEMME represents the first approved drug in a new antifungal class in over 20 years and is the first and only treatment for vaginal yeast infections which is both oral and non-azole.

INDICATION

BREXAFEMME is a triterpenoid antifungal indicated for the treatment of adult and post-menarchal pediatric females with vulvovaginal candidiasis (VVC) and for the reduction in the incidence of recurrent vulvovaginal candidiasis (RVVC).

DOSAGE AND ADMINISTRATION

The recommended dosage of BREXAFEMME for treatment of VVC is 300 mg (two tablets of 150 mg) administered approximately 12 hours apart (e.g., in the morning and in the evening) for one day, for a total daily dosage of 600 mg (four 150 mg tablets). The recommended dosage of BREXAFEMME in adult and post-menarchal females to reduce the incidence of RVVC is 300 mg (two tablets of 150 mg) administered approximately 12 hours apart (e.g., in the morning and in the evening) for one day, for a total daily dosage of 600 mg (four 150 mg tablets) monthly for 6 months. BREXAFEMME may be taken with or without food.

IMPORTANT SAFETY INFORMATION

There is a risk of embryo-fetal toxicity based on findings from animal studies. BREXAFEMME use is contraindicated in pregnancy.

For females of reproductive potential, verify that the patient is not pregnant prior to initiating treatment with BREXAFEMME. Reassessment of pregnancy status prior to each dose is recommended when BREXAFEMME is used monthly for 6 months for reduction in the incidence of RVVC.

Advise females of reproductive potential to use effective contraception during treatment of VVC and throughout the 6-month treatment period for reduction in the incidence of RVVC with BREXAFEMME and, for 4 days after the last dose.

BREXAFEMME is contraindicated in patients with a history of hypersensitivity to ibrexafungerp.

When administering BREXAFEMME with strong CYP3A inhibitors, the dose of BREXAFEMME should be reduced to 150 mg twice a day for one day. Administration of BREXAFEMME with strong CYP3A inducers should be avoided.

Most common adverse reactions observed in clinical trials (incidence ≥2%) of VVC were diarrhea, nausea, abdominal pain, dizziness, and vomiting. Most common adverse reactions observed in a clinical trial of RVVC were headache, abdominal pain, diarrhea, nausea, urinary tract infection and fatigue.

Reference:

SCYNEXIS Announces FDA Approval of Second Indication for BREXAFEMME (ibrexafungerp tablets) for Reduction in Incidence of Recurrent Vulvovaginal Candidiasis. SCYNEXIS. December 1, 2022. Accessed December 1, 2022. https://www.scynexis.com/news-media/press-releases/detail/314/scynexis-announces-fda-approval-of-second-indication-for