Loading...
The first member of a novel class of antifungal drugs was approved by the FDA in June 2021 for treating patients with vulvovaginal candidiasis (VVC). The drug, ibrexafungerp (Brexafemme), is given orally, in two doses over 12 hours. Approval was based on two unpublished placebo-controlled trials that are summarized in the drug's FDA-approved label. Almost 400 women in the U.S. and Bulgaria received ibrexafungerp for symptomatic VVC: At 1 to 2 weeks after treatment, 50% to 64% had complete clinical response, in contrast to 28% to 45% of 190 placebo recipients. At 4 weeks after treatment, 60% to 70% of ibrexafungerp recipients and 45% to 50% of placebo recipients had clinical resolution. Side effects consisted primarily of nausea, abdominal p…