FDA approves new treatment for molluscum contagiosum

SAN DIEGO – Ligand Pharmaceuticals Incorporated (Nasdaq: LGND) today announced that the U.S. Food and Drug Administration (FDA) has approved ZELSUVMI™ (berdazimer topical gel, 10.3%) for the treatment of adult and children 1 year of age and older. Mollusc infections and older age. This marks the first time the FDA has approved a new drug to treat molluscum contagiosum, providing a major advance in the treatment of this highly contagious skin disease.

ZELSUVMI™ is the first topical prescription medication that can be self-administered at home, providing new conveniences for patients and caregivers. The approval was based on results from two Phase 3 trials that demonstrated the drug’s ability to reduce the number of lesions with once-daily application and was well tolerated by patients.

Dr. Mark D. Kaufmann, clinical professor of dermatology and past president of the American Academy of Dermatology, expressed his expectations for this new treatment and noted its breakthrough status. Likewise, pediatrician and molluscologist Dr. Stephen W. Stripling emphasizes the benefits of effective treatment options at home versus the traditional “wait and see” approach.

Molluscum contagiosum affects approximately 6 million Americans each year, primarily children, and up to 73% of affected children receive no treatment. A hallmark of this condition is that if left untreated, the lesions can spread to other people or different parts of the body.

The mechanism of action of ZELSUVMI™, a nitric oxide releasing agent known for its antiviral properties, in the treatment of molluscum contagiosum is unknown. However, the effectiveness of ZELSUVMI™ was demonstrated in the B-SIMPLE clinical program, which involved 1,598 patients. The most common adverse reactions are application site reactions.

Ligand CEO Todd Davis expressed pride in the team’s achievement in completing the largest mollusk clinical program and receiving FDA approval for the first drug. The company expects ZELSUVMI™ to be available in the United States in the second half of 2024.

This news is based on a press release from Ligand Pharmaceuticals Incorporated.

This article was created and translated with the help of artificial intelligence and reviewed by an editor. For more information, please see our terms and conditions.