Novan submits NDA to FDA for Berdazimer Gel, 10.3%

Novan announced that the Company has submitted a New Drug Application to the U.S. Food and Drug Administration seeking marketing approval for berdazimer gel, 10.3% for the topical treatment of molluscum contagiosum. Assuming the filing is accepted by the FDA and given a typical 12-month review process, Novan anticipates a potential first quarter 2024 approval. Berdazimer gel, 10.3% is poised to be a first-in-class topical treatment for molluscum. The active ingredient, berdazimer sodium, is a new chemical entity that releases nitric oxide and has anti-viral activity. If approved, berdazimer gel, 10.3% would be the first effective and safe topical treatment indicated for molluscum with the convenience of self-application. Results from the pivotal Phase 3 B-SIMPLE4 clinical study evaluating berdazimer gel, 10.3% for the treatment of molluscumdemonstrated highly statistically significant improvement in primary clinical endpoint in the largest cohort of molluscum patients ever studied and were recently published in JAMA Dermatology. Berdazimer gel, 10.3% was found to be well tolerated with mild application site pain and mild to moderate erythema reported as the most common adverse events.