The US Food and Drug Administration (FDA) has approved Ligand Pharmaceuticals’ Zelsuvmi (berdazimer topical gel, 10.3%) to treat molluscum contagiosum (molluscum) in adults and paediatric patients aged one year and older. 

The decision makes the nitric oxide releasing agent the first and only topical prescription medication that can be applied by patients, parents or caregivers at home to treat molluscum. 

Approximately six million people in the US, primarily children, are infected every year with molluscum, a highly contagious viral skin infection characterised by lesions with a central, umbilicated viral core.

Despite treatment of the lesions being critical to preventing the infection from spreading to other people or to other areas of the body, up to 73% of children go untreated. 

The approval of Zelsuvmi was supported by two phase 3 trials that enrolled a total of 1,598 patients. Results from the B-SIMPLE 2 and B-SIMPLE4 studies demonstrated Zelsuvmi’s ability to reduce lesion counts, Ligand said, adding that the gel was well tolerated when used once daily. 

Commenting on the FDA’s decision, Ligand’s chief executive officer, Todd Davis, said: “We are proud of the team’s accomplishment, having completed the world’s largest clinical programme in molluscum to bring this first-in-class topical medication to FDA approval. 

"Paediatricians, 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.”

Stephen Stripling, paediatrician, study investigator and molluscum researcher, added: “It is nice to see that molluscum 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.”