At-Home Treatment for Molluscum Contagiosum Wins FDA Approval

The FDA approved the first at-home topical therapy for molluscum contagiosum, a highly contagious viral skin infection that primarily affects children.

The approval of berdazimer gel 10.3% (Zelsuvmi) includes adults and children ages 1 year and older. The medication can be applied outside a clinic by patients, parents, or caregivers, according to a statement from Ligand Pharmaceuticals.

"The approval of Zelsuvmi is a breakthrough, marking the first time that clinicians can treat molluscum with an efficacious topical prescription medication that is applied by the patient or a family member," said Mark D. Kaufmann, MD, of the Icahn School of Medicine at Mount Sinai in New York City, in the company statement.

Prompt treatment of molluscum contagiosum is essential to prevent the infection from spreading to other parts of the body or to other people. Even so, as many as three-fourths of children with the condition go untreated.

"It is nice to see that molluscum contagiosum is finally getting the attention it deserves," said Stephen W. Stripling, MD, a pediatrician in Charleston, South Carolina, and an investigator in clinical studies of molluscum contagiosum. "For those of us in the primary care field, it is wonderful to have an effective option that can be used at home rather than taking a wait-and-watch approach."

Berdazimer gel contains a nitric oxide-releasing agent, which has been shown to have antiviral properties, although the medication's precise mechanism of action is unknown. Support for the approval came from two randomized, phase III, vehicle-controlled trials involving 1,598 patients. After 12 weeks of once-daily treatment, almost 40% of patients had responded to topical berdazimer, including complete or near-complete response in about 30% of patients, a 10-15% improvement over the control group.

The most common adverse events associated with berdazimer were application-site reactions.

Berdazimer gel is expected to be available in the U.S. by the second half of 2024. The topical medication is the second approved treatment for molluscum contagiosum. Topical cantharidin (Ycanth), the first treatment specifically for the condition, received FDA approval in 2023.

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