SAN DIEGO - Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) announced today that the U.S. Food and Drug Administration (FDA) has approved ZELSUVMI™ (berdazimer topical gel, 10.3%) for treating molluscum contagiosum in adults and children one year and older. This marks the first FDA approval of a novel drug for molluscum infections, providing a significant advancement in the treatment of this highly contagious skin condition.
ZELSUVMI™ is the first topical prescription medication that can be self-applied at home, offering a new level of convenience for patients and caregivers. The approval is based on the results of two Phase 3 trials, which demonstrated the drug's ability to reduce lesion counts with a once-daily application and was well-tolerated by patients.
Dr. Mark D. Kaufmann, a Clinical Professor of Dermatology and Past President of the American Academy of Dermatology, expressed his anticipation for the availability of this new treatment, noting its breakthrough status. Similarly, Dr. Stephen W. Stripling, a pediatrician and molluscum researcher, highlighted the benefit of having an effective at-home treatment option over the traditional "wait and watch" approach.
Molluscum contagiosum affects approximately 6 million Americans each year, predominantly children, with up to 73% of affected children not receiving treatment. The condition is characterized by lesions that can spread the infection to others or different body areas if left untreated.
ZELSUVMI™, a nitric oxide releasing agent known for its antiviral properties, has an unknown mechanism of action in treating molluscum contagiosum. However, the efficacy of ZELSUVMI™ was established in the B-SIMPLE clinical program, involving 1,598 patients. The most common adverse reactions reported were application site reactions.
Ligand's CEO, Todd Davis, expressed pride in the team's achievement in completing the largest clinical program for molluscum and bringing this first-in-class medication to FDA approval. The company anticipates that ZELSUVMI™ will be commercially available in the United States during the second half of 2024.
This news is based on a press release statement from Ligand Pharmaceuticals Incorporated.
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