RARE Daily

FDA Grants Priority Review to Dupixent for Inflammatory Skin Condition

May 31, 2022

The U.S. Food and Drug Administration has granted Sanofi and Regeneron priority review to the supplemental Biologics License Application for Dupixent to treat adults with prurigo nodularis, a chronic inflammatory skin disease that causes extreme itch and skin lesions.

The agency is expected to act by September 30, 2022.

People with prurigo nodularis experience intense, persistent itch, with thick skin lesions (called nodules) that can cover most of the body. Prurigo nodularis is often described as painful with burning, stinging, and tingling of the skin. The impact of uncontrolled prurigo nodularis on quality of life is one of the highest among inflammatory skin diseases due to the extreme itch and is comparable to other debilitating chronic diseases that can negatively affect mental health, activities of daily living, and social interactions. High-potency topical steroids are commonly prescribed but are associated with safety risks if used long term. There are approximately 75,000 people in the U.S. who are unable to control their disease with systemic therapy and are most in need of a treatment option.

The supplemental application 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. Both trials met the primary and key secondary endpoints, showing Dupixent significantly improved disease signs and symptoms compared to placebo, including reduction in itch and skin lesions. 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. Sanofi and Regeneron are developing Dupixent under a global collaboration.

It is approved for use in certain patients with atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis, and eosinophilic esophagitis in different age populations in a number of countries around the world. Dupixent is currently approved across these indications in the United States and for one or more of these indications in the European Union, Japan, and more than 60 countries.

The FDA grants priority review to therapies that have the potential to provide significant improvements in the treatment, diagnosis or prevention of serious conditions. Additional regulatory filings outside of the U.S. are also planned in 2022. The potential use of Dupixent in prurigo nodularis is currently under clinical development, and the safety and efficacy have not been fully evaluated by any regulatory authority.

Author: Rare Daily Staff

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