NDA Sets Goal Date for Skin Infection Gel

The FDA has accepted Novan’s new drug application (NDA) seeking approval for berdazimer gel (SB206) to treat the skin infection molluscum contagiosum, an infection caused by a poxvirus. It is usually benign with mild skin disease characterized by lesions that may appear anywhere on the body. Within 6 to 12 months, Molluscum contagiosum 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.

Berdazimer sodium is a new chemical entity that releases nitric oxide and has anti-viral activity.

Paula Brown Stafford

The Prescription Drug User Fee Act (PDUFA) goal date is Jan. 5, 2024. If it is approved, the pharma maker would target launching in the first half of 2024, Novan chief executive officer Paula Brown Stafford told Formulary Watch. The wholesale acquisition cost for the medication has not yet been determined.

If the medication is approved, “it will be the first and only FDA-approved self-applied topical prescription medication for molluscum with proven safety and efficacy,” Brown Stafford said. “There is an unmet medical meet, as it can pervasively affect daily life, both functionally and emotionally for sufferers,” Brown Stafford added.

The FDA’s acceptance of the NDA 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 common adverse events were application-site pain and erythema, mostly mild in severity. Adverse events leading to discontinuation affected 4.1% of the berdazimer group and 0.7% of the vehicle group. The most common local skin reaction was mild to moderate erythema.