Sanofi and Regeneron's pipeline-in-a-drug Dupixent nabs priority review for yet another use

Sanofi and Regeneron’s Dupixent is on fire. A week after scoring the first FDA approval for eosinophilic esophagitis, the drug scored priority review for prurigo nodularis.

If it wins the agency's blessing, Dupixent would be the first FDA-approved treatment for the disease. The agency's target date for a decision is Sept. 30, Sanofi said Tuesday.

Dupixent's latest application is based on two phase 3 trials in patients with uncontrolled prurigo nodularis. Data from the trial showed Dupixent “significantly improved” symptoms, including a reduction in itch and skin lesions. The trials’ safety results generally matched with the known side effects in atopic dermatitis.

Prurigo nodularis is a chronic inflammatory skin condition that causes extreme, persistent itching and lesions that can cover most of the body. The intense itch can severely undercut quality of life and mental health for the approximately 75,000 U.S. patients who have not found relief through other treatments. High-potency topical steroids are a common go-to for the disease but can pose safety risks with long-term use.

Dupixent currently boasts other FDA approvals for patients with atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyps and, most recently, eosinophilic esophagitis. More than 400,000 patients worldwide have been treated with the drug. Sanofi and Regeneron are studying Dupixent in a range of diseases marked by type 2 inflammation or other allergic processes. Bill Sibold, Sanofi’s global head of specialty care, said in an investor call last month that new label expansions for the drug will add at least 1.5 million patients worldwide by 2025.

When CEO Paul Hudson joined Sanofi in 2019, he set out a “play to win” strategy to drive growth at the company. The strategy included a focus on Dupixent as a key growth driver. At the time, the ambition for the drug’s sales was 10 billion euros in peak sales from type 2 inflammatory indications.

Last year, the drug snagged 5.25 billion euros (around $6 billion), according to Sanofi's 2021 annual report (PDF). Executives project it will reach more than 13 billion euros annually.