FDA Approval of Topical Berdazimer Gel Announced for Molluscum Contagiosum

Press Release
Article

The FDA decision on berdazimer gel, 10.3%, represents the second approved treatment for the viral-borne skin disease.

The approval by the US Food and Drug Administration (FDA) of toical berdazimer gel (Zelsuvmi), 10.3%, was announced by Ligand Pharmaceuticals, Inc., for the treatment of pediatric and adult patients aged 1 year and older with molluscum contagiosum (moluscum).1

The treatment is the first novel drug formulated for the treatment of molluscum infections, as well as it is the first and the only topical drug applicable by caregivers or patients themselves. It can be applied outside of a clinician’s office as well.

“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, of the Icahn School of Medicine at Mount Sinai, said in a statement. “I look forward to having this novel medication to treat my molluscum patients.”

Berdazimer gel represents a new option for those with the viral and contagious skin infection, known for its characteristic skin-colored or red lesions. The announcement by Ligand acknowledges the 6 million Americans, mainly children, known to be impacted and often untreated each year.

The New Drug Application (NDA) for the berdazimer gel had been announced by Novan, Inc. originally, and it was with a Prescription Drug User Fee (PDUFA) goal date having been set for January 5, 2024.2 This submission had been based upon phase 3 findings from the B-SIMPLE4 trial.3

During the study, the berdazimer gel for molluscum led to improvements viewed as statistically significant in the study’s primary endpoint of complete clearance of all treatable molluscum after 12 weeks. The drug had also been well tolerated, with investigators noting only mild application site pain as well as mild to moderate erythema.

The FDA’s decision is significant as the only other approved treatment for molluscum contagiosum is Verrica Pharmaceuticals’ drug VP-102 (YCANTHE), a controlled formulation of cantharidin (0.7% w/v) formulated as a single-use applicator used for topical application and targeted delivery.4

VP-102 had been approved in July 2023 and represented the first available drug for molluscum. With the new approval of topical berdazimer gel, the treatment armamentarium for this viral-borne skin disease has expanded for clinicians.

“It is nice to see that molluscum contagiosum is finally getting the attention it deserves," Stephen W. Stripling, MD, Pediatrician, study investigator and researcher, said in a statement. "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.”1

References

  1. U.S. Food and Drug Administration Approves ZELSUVMI™ as a First-in-Class Medication for the Treatment of Molluscum Contagiosum. Ligand Pharmaceuticals. 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. Date accessed: January 5, 2024.
  2. Smith T. FDA Accepts Drug Application of Topical Antiviral Gel for Molluscum Contagiosum. HCPLive. March 7, 2023. https://www.hcplive.com/view/fda-accepts-drug-application-topical-antiviral-gel-molluscum-contagiosum. Date accessed: January 5, 2024.
  3. A phase 3 molluscum contagiosum efficacy and safety study (B-SIMPLE4). ClinicalTrials.gov identifier: NCT04535531. Updated January 26, 2023. https://clinicaltrials.gov/ct2/show/NCT04535531?cond=molluscum+contagiosum&draw=2&rank=. Date accessed: January 5, 2024.
  4. Smith T. FDA Approves VP-102 for Molluscum Contagiosum. HCPLive. July 21, 2023. https://www.hcplive.com/view/fda-approves-vp-102-molluscum-contagiosum. Date accessed: January 5, 2024.
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