The US Food and Drug Administration (FDA) announced its approval of Novan’s New Drug Application (NDA) for review of the topical antiviral treatment of molluscum contagiosum (Berdazimer Gel, 10.3%).¹

The company announced that the FDA had assigned a January 5, 2024, PDUFA date for the topical antiviral drug.

If the drug receives approval, it could become the US’s first FDA-approved prescription treatment for molluscum.

“We believe our (new chemical entity) can provide a much-needed therapeutic option for molluscum patients with the added benefit of being an easily applied, topical, self-administered treatment,” said Paula Brown Stafford, Novan’s President and CEO.

A highly contagious skin infection, molluscum contagiosum is known to affect around 6 million Americans, with a particularly high rate among children.

The decision follows the company’s phase 3 trial titled B-SIMPLE4, in which Berdazimer Gel 10.3% showed results that demonstrated statistical significance (P <.0001) for the investigators’ main endpoint.

Specifically, the results showed complete clearance after 12 weeks of all lesions, along with a solid safety profile and no serious adverse events reported by the research team.

“We are thrilled that the FDA determined our application is sufficiently complete, no filing review issues were identified, and that the substantive review process has commenced,” Stafford said.

References

1. Novan, Inc. 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. GlobeNewswire News Room. https://www.globenewswire.com/news-release/2023/03/07/2622009/0/en/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.html. Published March 7, 2023. Accessed March 7, 2023.
2. Browning JC, et al. Efficacy and Safety of Topical Nitric Oxide-Releasing Berdazimer Gel in Patients With Molluscum Contagiosum: A Phase 3 Randomized Clinical Trial. JAMA Dermatol. 2022 Aug 1;158(8):871-878. doi: 10.1001/jamadermatol.2022.2721. PMID: 35830173; PMCID: PMC9280611.