The Food and Drug Administration (FDA) has given its approval to ZELSUVMI, a topical medication designed to treat molluscum contagiosum, a highly contagious skin infection that most frequently affects children. This condition is characterized by red lesions with a central viral core.
Todd Davis, CEO of Ligand Pharmaceuticals, expressed his pride in the team's achievement. "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 Davis. He further emphasized the significance of this development for pediatricians, dermatologists, and caregivers who have been seeking a convenient treatment method for this infectious skin condition. "With ZELSUVMI, patients now have an at-home treatment option available," he added.
According to the Mayo Clinic’s webpage, molluscum contagiosum is common but easily spread through person-to-person contact or when the small round bumps characteristic of the disease are scratched or disturbed. These bumps are raised, skin-colored and approximately a quarter of an inch in diameter. They can cause itching and appear on various parts of the body including the face, arms, body or legs. For adults, transmission can occur through sexual activity resulting in bumps appearing on inner thighs or lower abdomen. If left untreated and if bumps appear on eyelids, it can lead to pink eye.
Mark D. Kaufmann, MD, FAAD, Clinical Professor of Dermatology at the Icahn School of Medicine at Mount Sinai in New York City and Past President of the American Academy of Dermatology described this approval as a breakthrough. "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," Kaufmann said. He expressed his anticipation for using this novel medication to treat his patients suffering from molluscum.
ZELSUVMI, which contains the active ingredient berdazimer, was officially approved by the FDA as a novel drug on January 5, 2024.
Stephen W. Stripling, MD, Pediatrician, Study Investigator and Molluscum Researcher expressed his satisfaction with this development. "It is nice to see that molluscum contagiosum is finally getting the attention it deserves. 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," said Stripling.