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June 2, 2021 – The U.S. FDA has approved Brexafemme® (ibrexafungerp), manufactured by Scynexis, to treat vulvovaginal candidiasis (VVC) in adult and postmenarchal pediatric females. Brexafemme is the first FDA-approved drug in a new antifungal class in more than two decades, and the first and only FDA- approved oral non-azole treatment for vaginal yeast infections.
VCC is a common type of vaginal yeast infection caused by Candida yeast species, including species resistant to fluconazole, a current standard of care. Candida yeast are a normally harmless type of fungus often found on the skin and inside the body. However, Candida can become infectious if it grows out of control or enters deeper parts of the body where it typically shouldn’t be, such as the bloodstream.
In a clinical trial, Brexafemme demonstrated efficacy and a favorable tolerability profile in female patients diagnosed with VVC. It attacks and kills the cells of Candida species through an antifungal mechanism of action cased glucan synthase inhibition, which prevents Candida species from forming the protective cell walls they need to survive.
Recommended dosing is 300mg (two 150mg tablets) taken by mouth twice in one day, for a total treatment dosage of 600mg. Each 300mg dose should be taken approximately 12 hours apart and can be taken with or without food. Dose modification may be required depending on other medications the patient is taking.
Scynexis plans to launch Brexafemme in the second half of 2021, in partnership with Amplity Health.