Less than six months after Ligand Pharmaceuticals swooped in to buy Novan’s assets following the latter company’s bankruptcy, the purchase has paid off with an FDA approval.
Late Friday, the FDA approved Ligand’s Zelsuvmi for the treatment of molluscum contagiosum in patients ages 1 and older. With the nod, Ligand’s topical gel becomes the first at-home treatment for the highly contagious viral skin infection.
Zelsuvmi can be applied by patients, parents or others to treat a condition that's marked by lesions on the skin.
The FDA approved the drug based on a pair of phase 3 studies that enrolled a total of 1,598 patients. In the B-SIMPLE 2 and B-SIMPLE4 studies, the drug showed an ability to reduce the number of lesions compared with a vehicle gel, according to Ligand.
“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,” pediatrician and study investigator Stephen Stripling, M.D., said in a statement.
Before those approval-enabling results, another company, Novan, in early 2020 reported a pair of phase 3 failures that left the med’s future in doubt.
After that setback, Novan tried to press forward with its candidate but eventually had to file for bankruptcy. In July 2023, Ligand stepped in to buy out Novan's assets.
About 6 million people are infected with molluscum each year in the U.S., according to Ligand, with most being children.
Besides Ligand's drug, Verrica's Ycanth won an FDA approval in this indication last year.
Ligand plans to make Zelsuvmi available in the second half of 2024.
Editor's note: This story was corrected to note that Ycanth won an FDA approval to treat molluscum contagiosum last year.