NDA submitted to the FDA for berdazimer gel, 10.3% for the treatment of molluscum contagiosum.- Novan Inc.,
Novan, Inc. announced that the Company has submitted a New Drug Application (NDA) to the FDA seeking marketing approval for berdazimer gel, 10.3% (SB 206) for the topical treatment of molluscum contagiosum (“molluscum”). 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 III B-SIMPLE4 clinical study evaluating berdazimer gel, 10.3% for the treatment of molluscum (NCT04535531) demonstrated highly statistically significant improvement in primary clinical endpoint (p<0.0001) 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..></0.0001)>
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