FDA approves BREXAFEMME® as the first and only oral non-azole treatment for vulvovaginal candidiasis
Posted on June 07, 2021
The U.S. Food and Drug Administration has approved BREXAFEMME®(ibrexafungerp) as the first and only oral non-azole treatment for vulvovaginal candidiasis (VVC) also known as vaginal yeast infections.
BREXAFEMME was approved based on positive results from the two Phase 3 studies in which oral ibrexafungerp demonstrated efficacy and a favorable tolerability profile in women with vaginal yeast infections. BREXAFEMME is the first approved drug in a novel antifungal class in more than 20 years and a much needed, new treatment option for the millions of women who suffer from vaginal yeast infections. BREXAFEMME has a differentiated fungicidal mechanism of action that kills a broad range of Candida species, including azole-resistant strains.
VVC, commonly known as a vaginal yeast infection due to Candida, is the second most common cause of vaginitis. Although these infections are frequently caused by Candida albicans, infections caused by fluconazole-resistant and non-albicans Candida strains, such as Candida glabrata, have been reported to be on the rise. VVC can be associated with substantial morbidity, including significant genital discomfort (pain, itching, burning), reduced sexual pleasure and activity, psychological distress (stress, depression, anxiety), embarrassment, reduced physical activity, and loss of productivity. Typical VVC symptoms include pruritus, vaginal soreness, irritation, excoriation of vaginal mucosa and abnormal vaginal discharge. An estimated 70-75% of women worldwide will have at least one episode of VVC in their lifetime, and 40-50% of them will experience multiple episodes.
Currently approved treatments for VVC include BREXAFEMME (ibrexafungerp tablets), several topical antifungals, and oral fluconazole, which is the only other orally administered antifungal approved for the treatment of VVC in the U.S. and which has typically accounted for over 90% of the prescriptions written for this condition every year.