The effectiveness of Zelsuvmi was proven in the B-SIMPLE 4 and B-SIMPLE 2 Phase 3 trials in which the drug, when taken once daily, was well tolerated and could lower lesion counts
A high-magnification micrograph of molluscum. (Credit: Nephron from Wikimedia Commons)
Ligand Pharmaceuticals has received the US Food and Drug Administration (FDA) approval for Zelsuvmi (berdazimer topical gel, 10.3%) to treat molluscum contagiosum in adults and paediatric patients of age one year and older.
Zelsuvmi is a nitric oxide (NO) releasing agent designed for the topical treatment of molluscum contagiosum, a highly contagious viral skin infection.
The topical prescription medication is said to be the first FDA-approved drug to treat molluscum infections.
It can be applied by patients, parents, or caregivers at home, outside of a physician’s office, or in other medical settings for this infection treatment.
Ligand Pharmaceuticals CEO Todd Davis said: “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.
“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.”
The effectiveness of Zelsuvmi was proven in the B-SIMPLE 4 and B-SIMPLE 2 Phase 3 trials.
These studies demonstrated that the drug, when taken once daily, was well tolerated and could lower lesion counts.
In Phase 3 of the B-SIMPLE programme, 1,598 patients were enrolled. The most often reported adverse reactions (≥1%) in clinical trials were the application site reactions.
Study investigator and molluscum researcher Stephen Stripling said: “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.”
Zelsuvmi is anticipated to be available in the US in the second half of this year.