Ligand Pharmaceuticals Inc. has announced that its topical treatment for a viral skin infection, Zelsuvmi, has received approval from the U.S. Food and Drug Administration (FDA). This marks a significant development as Zelsuvmi becomes the first at-home medication for viral skin infection in the United States.
The gel, Zelsuvmi, is expected to be available in the U.S. market in the second half of 2024. While the pricing details are yet to be established, Ligand’s shares experienced a positive surge of approximately 5% in extended trading following the announcement.
Zelsuvmi is designed to treat molluscum contagiosum, a highly contagious skin infection caused by a poxvirus. The infection typically results in skin lesions that generally resolve within a year without scarring, though in some cases, the resolution can take longer. According to the company, about 6 million people, primarily children aged 1-14 years, are affected by this disorder in the U.S. annually.
The newly approved treatment is set to compete with Verrica Pharmaceuticals’ Ycanth, which received approval last year as the first U.S.-approved treatment for molluscum contagiosum. However, Ycanth requires medical supervision during application, distinguishing Zelsuvmi as an at-home alternative.
Zelsuvmi is a topical nitric oxide-releasing agent containing an active ingredient known as Berdazimer Sodium. Ligand had initially provided funding to Novan for the clinical development of the berdazimer gel in 2019. However, when Novan filed for bankruptcy, Ligand acquired the drug and another asset for $12.2 million.
The FDA’s approval of Zelsuvmi was based on late-stage trial data indicating that the berdazimer gel successfully met its primary goal of achieving complete clearance of lesions. After 12 weeks of treatment, 32.4% of patients treated with the berdazimer gel achieved complete clearance of the skin infection, a significant improvement compared to the 19.7% in the control group not given the active drug ingredient.
The availability of Zelsuvmi as an at-home treatment option holds promise for individuals affected by molluscum contagiosum, providing a convenient and effective solution for this common viral skin infection.