New Drug Application Accepted by the Food and Drug Administration for Berdazimer Gel 10.3%

The US Food and Drug Administration (FDA) recently announced its acceptance of a new drug application for Novan’s berdazimer gel 10.3% for the treatment of molluscum contagiosum.¹

Berdazimer gel 10.3% is a topical antiviral gel typically utilized for the treatment of viral skin infections.² Currently, it is in development for the treatment of molluscum contagiosum. A recent phase 3 trial (B-SIMPLE4) showcased positive efficacy results with complete clearance of all lesions by week 12.² Berdazimer gel 10.3% presented a favorable safety profile with no related serious adverse events. There were an additional 2 phase 3 studies completed, which displayed similar results.²

Molluscum contagiosum is a contagious skin infection caused by the molluscipoxvirus. There are currently no FDA-approved therapies for molluscum. About more than half of the patients diagnosed with molluscum are untreated, with over 30% receiving an off-label prescription with no molluscum indication or proven clinical efficacy while being treated.²

“We believe our NCE [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,” Paula Brown Stafford, president and chief executive officer of Novan stated.¹ “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,” she concluded.

References
1. 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. News Release. Novan. March 07, 2023. Accessed March 30, 2023. 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

2. Berdazimer gel 10.3% (SB206) in development for the treatment of molluscum contagiosum. News Release. Novan. March 07, 2023. Accessed March 30, 2023. https://novan.com/berdazimer-gel-10-3-sb206