FDA Approves First Drug for Skin Infection from Pox Virus

The FDA has approved Ycanth (cantharidin) for the topical treatment of molluscum contagiosum in adult and pediatric patients 2 years of age and older as an in-office administered therapy. Developed by Verrica Pharmaceuticals, Ycanth (perviously VP-102) is the first FDA-approved treatment for molluscum, a highly contagious viral skin infection affecting about 6 million people annually in the United States. Molluscum is caused by a pox virus that produces raised, skin-toned-to-pink-colored lesions that can cause pain, inflammation, itching and bacterial infection.

Ycanth is a drug-device combination product that contains cantharidin (0.7% w/v) delivered via a single-use applicator. It will be available by September 2023. The company has not yet released information on pricing.

At a presentation for investors, company officials indicated that payers recognize the unmet need in treating molluscum. Payers in both commercial and Medicaid markets — representing more than 205 million lives — have indicated they will provide coverage on the medical benefit side. Minimal rebates will be required, company officials said.

Ted White

“Today's approval of Ycanth is a historic transformational moment in medical dermatology, as physicians, patients and caregivers have long sought a safe and effective FDA approved treatment for molluscum. Molluscum, which primarily affects children, is highly contagious and is commonly transmitted in households, schools, swimming pools and other extra-curricular settings,” Ted White, Verrica’s president and CEO, said in a press release.

The approval was based on data from two studies that enrolled 528 patients. Patients received treatment or placebo at 21-day intervals until bumps were completely cleared or for a maximum of four applications. In the studies, 54% of patients treated with Ycanth achieved complete clearance of all treated molluscum bumps by day 84 compared with 13% of those who were treated with placebo.

The most common adverse reactions to Ycanth occurred at the application site, and included blistering, pain, itching, scabbing, reddening, discoloration, dryness, edema (swelling), and erosion of the skin.

In February 2023, Verrica had resubmitted its NDA for the Ycanth. In May 2022, the FDA had issued a complete response letter (CRL). The agency had identified deficiencies at Sterling Pharmaceuticals, the contract manufacturing organization that manufactures Verrica’s bulk solution drug product.