FDA Approves Sanofi and Regeneron’s Dupixent as First and Only Treatment for Prurigo Nodularis

The U.S. Food and Drug Administration has approved Sanofi and Regeneron’s Dupixent for the treatment of adult patients with prurigo nodularis, as the first and only medicine specifically indicated to treat prurigo nodularis in the United States.

Photo: George Yancopoulos, president and chief scientific officer of Regeneron

Prurigo nodularis is a chronic, debilitating skin disease with underlying type 2 inflammation and its impact on quality of life is one of the highest among inflammatory skin diseases. People with prurigo nodularis experience intense, persistent itch with thick skin lesions (called nodules) that can cover most of the body. The disease is often painful, with burning, stinging, and tingling of the skin, impacting quality of life due to the extreme itch 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 about 75,000 adults in the United States living with prurigo nodularis and are most in need of new treatment options.

“With this approval, those suffering with prurigo nodularis finally have a medicine to address the debilitating signs and symptoms of the disease,” said George Yancopoulos, president and chief scientific officer of Regeneron.

The FDA approval is based on data from two phase 3 trials, PRIME and PRIME2, evaluating the efficacy and safety of Dupixent in adults with prurigo nodularis. Efficacy in these trials assessed the proportion of subjects with clinically meaningful reduction in itch, clearing of skin, or both. About three times as many Dupixent patients (60 percent and 58 percent) experienced a clinically meaningful reduction in itch from baseline at 24 weeks, compared to 18 percent and 20 percent for placebo, the primary endpoint in PRIME. Forty four percent and 37 percent of Dupixent patients experienced a clinically meaningful reduction in itch from baseline at 12 weeks, compared to 16 percent and 22 percent for placebo, the primary endpoint in PRIME2. More than twice as many Dupixent patients achieved clear or almost clear skin at 24 weeks, compared to placebo. More than three times as many Dupixent patients experienced both a clinically meaningful reduction in itch and clear or almost clear skin, compared to placebo patients at 24 weeks.

The safety results of the trial were generally consistent with the known safety profile of Dupixent in its approved dermatology indication. The most common adverse events (≥2 percent) from pooled PRIME and PRIME2 data more frequently observed with Dupixent than placebo were nasopharyngitis, conjunctivitis, herpes infection, dizziness, muscle pain, and diarrhea.

Dupixent (dupilumab) is a fully human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways and is not an immunosuppressant. The Dupixent development program has shown significant clinical benefit and a decrease in type 2 inflammation in phase 3 trials, establishing that IL-4 and IL-13 are key and central drivers of the type 2 inflammation that plays a major role in multiple related and often co-morbid diseases. These diseases include approved indications for Dupixent such as prurigo nodularis, atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis, and eosinophilic esophagitis.

“Dupixent has the potential to transform the standard-of-care for prurigo nodularis patients by alleviating the key hallmarks of the disease, such as reducing itch and achieving clearer skin,” said Naimish Patel, head of Global Development, Immunology and Inflammation, Sanofi. “With Dupixent now approved in two diseases in dermatology where type 2 inflammation is a central driver, we look forward to further evaluating the potential of inhibiting IL-4 and IL-13 in other chronic skin diseases.”

Dupilumab is being jointly developed by Sanofi and Regeneron under a global collaboration agreement. To date, dupilumab has been studied across more than 60 clinical trials involving more than 10,000 patients with various chronic diseases driven in part by type 2 inflammation.

The FDA evaluated the Dupixent application for prurigo nodularis under Priority Review, which is granted to therapies that have the potential to provide significant improvements in the treatment, diagnosis or prevention of serious conditions.

A regulatory filing for prurigo nodularis is under review by the European Medicines Agency, and submissions to regulatory authorities in additional countries are also planned in 2022.

Author: Rare Daily Staff