FDA approves Zelsuvmi for molluscum contagiosum
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Key takeaways:
- Berdazimer gel 10.3% is the first prescription treatment approved for molluscum contagiosum.
- In a phase 3 clinical trial, skin lesion reduction was seen in 57.5% of those treated with berdazimer gel.
Topical Zelsuvmi has been approved by the FDA for use in patients aged 1 year and older with molluscum contagiosum, Ligand Pharmaceuticals announced in a press release.
A topical antiviral gel, Zelsuvmi (berdazimer gel 10.3%) releases nitric oxide upon application and has an antimicrobial effect. It is the first prescription treatment indicated for the viral skin infection that mostly affects children.
“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,” Mark D. Kaufmann, MD, FAAD, a clinical professor in the department of dermatology at Icahn School of Medicine at Mount Sinai and past president of the American Academy of Dermatology, said in the release. “I look forward to having this novel medication to treat my molluscum patients.”
The approval was based on data from the B-SIMPLE phase 3 program, in which 32.4% of patients treated with berdazimer gel experienced complete lesion clearance at week 16 compared with 19.7% of those treated with vehicle and an overall reduction in lesions was observed in 57.5% of those in the treatment group vs. 31% in the vehicle group.
Developed by Novan Pharmaceuticals, Zelsuvmi was acquired by Ligand in July 2023 when Novan filed for chapter 11 bankruptcy protection and Ligand bought the company’s assets.
Reference:
- Novan enters into agreement to sell substantially all of its assets, including berdazimer gel, 10.3% (SB206), and files for chapter 11 protection. Novan Enters into Agreement to Sell Substantially All of its Assets, including Berdazimer Gel, 10.3% (SB206), and Files for Chapter 11 Protection - Novan. Published July 17, 2023. Accessed Jan. 8, 2024.