FDA Gives Nod to Berdazimer Gel for Molluscum Contagiosum

The Food and Drug Administration approved berdazimer gel 10.3% for the treatment of molluscum contagiosum (MC) in adults and children aged 1 year or older. The approval was based on a 12-week pivotal phase 3 trial in which the gel helped 32.4% of patients achieve complete clearance of MC lesions compared with 19.7% of those in the placebo group. Only 4.1% of patients on berdazimer experienced adverse events that led to discontinuation of treatment. The drug, marketed under the name Zelsuvmi, is expected to be available in the second half of 2024, making it the first and only topical prescription medication for at-home treatment of MC. On July 21, 2023, topical cantharidin became the first approved treatment of MC for adults and pediatric patients aged 2 years or older.

Source link