FDA Approves Gel for Skin Infection Caused by Poxvirus

The FDA has approved Ligand Pharmaceuticals’ Zelsuvmi (berdazimer) to treat patients with molluscum contagiosum, an infection caused by a poxvirus. It is indicated for patients one year of age and older and is a first-in-class topical drug approved to treat molluscum infections.

Molluscum contagiosum is a contagious infection that presents as mild skin lesions. Within six to 12 months, it typically resolves without scarring but may take as long as four years, according to the CDC. It affects about 6 million people — mostly children — in the United States. Molluscum is transmitted by human contact or via a contaminated object, such as a towel at the pool or an athletic mat.

Zelsuvmi is nitric oxide releasing agent, which has been shown to have antiviral properties. It is expected to be available in the second half of 2024. Pricing information is not yet available. A company spokesperson indicated that they have begun efforts to discuss coverage with payers.

Zelsuvmi was developed by Novan, which filed for bankruptcy in July 2023. Ligand acquired Novan’s berdazimer, the Nitricil technology and the Bayer-partner Sitavig program for $15 million and also agreed to provide up to $15 million in debtor-in-possession financing.

The FDA’s FDA was based on a results of the B-SIMPLE 4 pivotal phase 3 clinical study published in JAMA Dermatology. The multicenter vehicle-controlled, double-blind study enrolled 891 patients that were across 55 clinics in the United States. At the end of 12 weeks, 32.4% of patients in the berdazimer group achieved complete clearance of lesions, compared with 19.7% in the vehicle group.

Adverse event rates were low. The most commonly reported adverse reactions were application site reactions including pain such as burning or stinging sensations, erythema, itching, exfoliation, dermatitis, swelling, erosion, discoloration, vesicles, irritation, and infection.