Zelsuvmi Gets FDA Nod to Become Second Approved Treatment After Ycanth for Molluscum Contagiosum

The US Food and Drug Administration (FDA) has given the nod to Ligand Pharmaceuticals’ topical antiviral Zelsuvmi (berdazimer gel 10.3%) for the treatment of molluscum contagiosum in adult and pediatric patients one year of age and older.

The topical gel is the first approved treatment that can be used outside of a medical setting. It can be applied by patients, parents, caregivers or others at home, outside of a physician’s office, to treat the highly contagious viral skin infection, according to Ligand.

Molluscum contagiosum is caused by infection with a poxvirus (molluscum contagiosum virus). It primarily affects children and results in the formation of painless, yet unsightly skin lesions. These lesions, which are skin colored to red are generally harmless but can cause significant discomfort as well as social stigma, particularly for younger patients.

Last summer, Verrica Pharmaceuticals’ topical Ycanth (cantharidin) received FDA approval as the first treatment for molluscum contagiosum. Prior to and in addition to Ycanth now, standard treatments for the infection included physical removal using cryotherapy, curettage (surgical scraping) or laser therapy, and oral cimetidine, especially for young children as it is less painful than physical removal.

Related: Ycanth (Cantharidin) Revolutionizes Molluscum Contagiosum Treatment with FDA Approval

Molluscum contagiosum is a common skin infection that affects nearly 6 million individuals every year in the US. Concerningly, 73 percent of children with the infection go untreated. It is crucial to treat the lesions to prevent spreading of the infection to other parts of the body or to other individuals.

Ligand obtained Zelsuvmi in its $12.2 million purchase of Novan’s assets, completed last September after the company filed for bankruptcy. In 2019, Ligand had given Novan funding to develop the drug in exchange for milestones and royalties but ended up acquiring it outright through the 2023 buyout. Zelsuvmi’s future was also in question after the drug had failed in two of Novan’s Phase III trials. However, less than six months later, Ligand’s gamble paid off with an approval.

Zelsuvmi is a nitric oxide-releasing agent; nitric oxide has been shown to have antiviral properties, specifically inhibiting viral replication. However, the exact mechanism of action of Zelsuvmi in its treatment of molluscum contagiosum is unknown, said Ligand.

The FDA’s approval of Zelsuvmi was based on data from two Phase III clinical trials, B-SIMPLE 4 and B-SIMPLE 2, involving 1,598 patients. The results showed that once-daily treatment with the berdazimer gel led to a significant decrease in lesion count compared to participants that received a placebo gel, with a favorable safety profile. Specifically, after 12 weeks of treatment, 32.4 percent of patients treated with Zelsuvmi achieved complete clearance of the infection compared to 19.7 percent who were given placebo.

The most commonly reported adverse reactions (≥ one percent) in the trials were application site reactions.

Ligand said it expects Zelsuvmi to be available in the US in the second half of 2024. The price of Zelsuvmi has not yet been released by the company.