FDA Accepts Dupixent Application for Treating Skin Lesions

If approved, Dupixent would be the first and only medicine in the United States specifically indicated to treat prurigo nodularis, or persistent itch with thick skin lesions. The PDUFA target action date for the FDA decision is Sept. 30, 2022.

The FDA has accepted for priority review the supplemental biologics license application (sBLA) for Dupixent (dupilumab) to treat adults with prurigo nodularis, a chronic inflammatory skin disease that causes extreme itch and skin lesions. The target action date for the FDA decision is September 30, 2022.

Dupixent is a human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways and is not an immunosuppressant. It is being developed jointly by Sanofi and Regeneron.

The sBLA is supported by data from two pivotal phase 3 trials evaluating the efficacy and safety of Dupixent in patients 18 years and older with uncontrolled prurigo nodularis (PRIME2 and PRIME). Both trials met the primary and key secondary endpoints, showing Dupixent significantly improved disease signs and symptoms compared with placebo, including reduction in itch and skin lesions.

Topline results from the PRIME2 study were released at the Academy of Dermatology 2022 Annual Meeting. In this study, 37% of Dupixent patients experienced a clinically meaningful reduction in itch from baseline compared with 22% of placebo patients at week 12, the primary endpoint. Nearly three times as many Dupixent patients experienced a clinically meaningful reduction in itch from baseline at week 24: 58% of Dupixent patients compared with 20% of placebo patients.

The safety results from these trials were generally consistent with the known safety profile of Dupixent in atopic dermatitis. The adverse event more commonly observed with Dupixent was conjunctivitis.

Dupixent is approved for use in certain patients with atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis and eosinophilic esophagitis in different age populations.

Its most recent approval in May 2022 was to treat patients with eosinophilic esophagitis, an inflammatory condition that causes the esophagus to narrow and makes it difficult to eat.

Related: FDA Approves Dupixent for Eosinophilic Esophagitis