FDA Approves Berdazimer Gel, 10.3% for the Treatment of Molluscum Contagiosum

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The US Food and Drug Administration (FDA) announced today its approval of Ligand Pharmaceuticals Incorporated's berdazimer gel, 10.3% for the treatment of molluscum contagiosum in patients ages 1 year and older.¹

This approval makes berdazimer gel only the second FDA-approved treatment for this indication, following the approval of Verrica Pharmaceutical's Ycanth (formerly VP-102) in July of last year.

“The approval of [berdazimer gel] 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,” said Mark D. Kaufmann, MD, FAAD, clinical professor of Dermatology in the department of dermatology at the Icahn School of Medicine at Mount Sinai in New York, New York and past president of the American Academy of Dermatology, in a press release. “I look forward to having this novel medication to treat my molluscum patients.”

The approval comes just under a year after the FDA accepted its New Drug Application (NDA) for berdazimer in March of 2023.²

The NDA and approval are based on positive data stemming from the B-SIMPLE4 (NCT04535531) trial, published in the Journal of the American Medical Association Dermatology.³

In the phase 3 study, berdazimer gel demonstrated statistically significant improvements in the clearance of treatable molluscum contagiosum at week 12.

Additionally, berdazimer gel was well-tolerated among patients, with the most common adverse events reported as being mild application site pain and mild-to-moderate erythema.

Key outcomes of the study also included a lesion count of 0 or 1 of all treatable molluscum contagiosum at week 12, a 90% reduction from baseline in the number of all treatable molluscum contagiosum at week 12, complete clearance of all treatable molluscum contagiosum at week 8, and a change from baseline in the number of all treatable molluscum contagiosum at week 4.

The approval of berdazimer gel, 10.3% marks a significant milestone in the treatment of this burdensome, highly contagious condition.

Authors of the B-SIMPLE4 study wrote, "Molluscum contagiosum infection is usually self-limited, yet may persist for months to years, generating a substantial health care burden and quality-of-life concerns necessitating therapeutic intervention. Treatment may also be warranted because of its highly contagious nature and concern for infecting peers or household members. Additionally, outwardly visible lesions may be associated with discomfort and psychosocial stigma, and may scar after resolution.”

References

1. US Food and Drug Administration approves ZELSUVMI as a first-in-class medication for the treatment of molluscum contagiosum. Ligand Pharmaceuticals. Press release. January 5, 2024. Accessed January 5, 2024. https://investor.ligand.com/news-and-events/press-releases/news-details/2024/U.S.-Food-and-Drug-Administration-Approves-ZELSUVMI-as-a-First-in-Class-Medication-for-the-Treatment-of-Molluscum-Contagiosum/default.aspx
2. FDA accepts Novan’s NDA for berdazimer gel, 10.3% for the treatment of molluscum contagiosum with a PDUFA goal date of January 5, 2024. Novan Inc. Published March 7, 2023. Accessed January 2, 2024. https://novan.com/fda-accepts-novans-nda-for-berdazimer-gel-10-3-for-the-treatment-of-molluscum-contagiosum-with-a-pdufa-goal-date-of-january-5-2024/