FDA accepts NDA for berdazimer gel to treat molluscum contagiosum

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Following positive results from a phase 3 clinical trial, the FDA has accepted a New Drug Application for berdazimer gel, 10.3% (Novan) for treating patients with molluscum contagiosum.

The FDA has accepted a New Drug Application (NDA) for berdazimer gel, 10.3% (SB206; Novan) for the treatment of patients with molluscum contagiosum (MC). The FDA target action date is January 5, 2024.1

The application is backed by data from a phase 3 randomized clinical trial, B-SIMPLE4.2 Patients were eligible if they were immunocompetent, aged 6 months and older, had generally good health, and had 3 to 70 MC lesions raised and touchable.

Exclusion criteria included having a sexually transmitted MC, MC in only the periocular area, and being unable to treat and accurately count lesions. All patients were included in the intention-to-treat (ITT) set. Patients who received 1 or more application of study medication made up a safety set receiving safety analysis, while the ITT set underwent an efficacy analysis.

Study visits took place at baseline, 2 weeks, 4 weeks, 8 weeks, 12 weeks, and 24 weeks. A thin layer of medication was applied once per day by the participants or caregivers during all study visits except the last. Medication was applied to known lesions at baselines, along with lesions that presented afterward up to week 12.

Randomization to berdazimergel or vehiclegroups was 1:1, with patients from the same household receiving the same treatment. At all study visits except the last, the amount of active MC lesions on a patient was counted. MC severity was assessed on a 5-point scale, while adverse events were recorded throughout the study.

The primary outcome was the difference in patients who achieved complete clearance of treatable MC lesions at week 12 in the berdazimer gel and vehicle groups. Complete clearance was seen in 32.4% of the berdazimergel group and 19.7%of the vehicle group, showing improved efficacy when using berdazimer gel.

The rate of adverse events was also low, with mild to severe application-site pain and erythema being the most common adverse events. Favorable safety and efficacy results were seen overall in patients taking berdazimer gel, 10.3%.

Reference

1. FDA accepts Novan’s NDA for berdazimergel, 10.3% for the treatment of molluscum contagiosum with a PDUFA goal date of January 5, 2024. BioSpace. March 7, 2023. Accessed March 7, 2023. https://www.biospace.com/article/releases/fda-accepts-novan-s-nda-for-berdazimer-gel-10-3-percent-for-the-treatment-of-molluscum-contagiosum-with-a-pdufa-goal-date-of-january-5-2024/#:~:text=FDA%20Accepts%20Novan's%20NDA%20for,Date%20of%20January%205%2C%202024

2. Browning JC, Enloe C, Cartwright M, et al. Efficacy and safety of topical nitric oxide−releasing berdazimergel in Patients With molluscum contagiosum: aphase 3 randomized clinical trial. JAMA Dermatol. 2022;158(8):871–878. doi:10.1001/jamadermatol.2022.2721

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