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U.S. Food and Drug Administration approves ZELSUVMI to treat molluscum contagiosum

The U.S. Food and Drug Administration (FDA) has approved Ligand Pharmaceuticals’ ZELSUVMI (berdazimer topical gel, 10.3%) for the treatment of molluscum contagiosum (molluscum) in adults and pediatric patients one year of age and older. The FDA approved ZELSUVMI as the first novel drug for the treatment of molluscum infections.

ZELSUVMI is the first and only topical prescription medication that can be applied by patients, parents, or caregivers at home, outside of a physician’s office, or other medical setting to treat this highly contagious viral skin infection.

“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, FAAD, a Clinical Professor of Dermatology in the Department of Dermatology at the Icahn School of Medicine at Mount Sinai in New York City and Past President of the American Academy of Dermatology. “I look forward to having this novel medication to treat my molluscum patients.”

Molluscum is a highly contagious viral skin infection characterized by skin-colored to red lesions with a central, umbilicated viral core. Approximately 6 million Americans, primarily children, are infected each year. However, up to 73% of children go untreated. Treating the lesions is critical to preventing the viral infection from spreading to other people or to other areas of the body.

ZELSUVMI is a nitric oxide releasing agent. Nitric oxide has been shown to have antiviral properties. The mechanism of action of ZELSUVMI for the treatment of molluscum contagiosum is unknown. Nevertheless, ZELSUVMI’s efficacy was demonstrated in 2 Phase 3 trials – B-SIMPLE 4 and B-SIMPLE 2. These trials showed ZELSUVMI’s ability to reduce lesion counts and was well tolerated when used once a day. The B-SIMPLE Phase 3 program enrolled 1,598 patients. The most commonly reported adverse reactions (≥1%) in clinical trials were application site reactions.

“We are proud of the team’s accomplishment, having completed the world’s largest clinical program in molluscum to bring this first-in-class topical medication to FDA approval,” said Todd Davis, CEO of Ligand. “Pediatricians, dermatologists, and caregivers have long-sought a convenient approach to treat this highly contagious skin infection. With ZELSUVMI, patients now have an at-home treatment option available.”

 

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