The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion, recommending approval of Dupixent (dupilumab) in the European Union (EU) for the treatment of adults with moderate to severe prurigo nodularis who are candidates for systemic therapy.
Dupilumab is being jointly developed by Sanofi and Regeneron.
The European Commission is expected to announce a final decision on the Dupixent app in the coming months. In September 2022, Dupixent was passed by the US Food and Drug Administration for the treatment of adult patients with prurigo nodularis.
Prurigo nodularis is a chronic and debilitating skin disease with underlying type 2 inflammation and has one of the greatest impacts on a patient’s quality of life among inflammatory skin diseases due to the extreme itching it causes. People with prurigo nodularis experience intense, persistent itching 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, and 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.
The CHMP’s positive opinion is supported by data from two phase 3 trials, showing that Dupixent significantly reduced itching (the primary endpoint) and skin lesions compared to placebo. Dupixent also significantly improved health-related quality of life while reducing measures of skin pain and anxiety/depression symptoms. The safety results of the trial were generally consistent with the known safety profile of Dupixent in its approved dermatological indication. The most commonly observed adverse events with Dupixent compared to placebo included conjunctivitis.
The use of Dupixent in adults with moderate to severe nodular prurigo is under investigation in the EU and is not yet approved.
Dupixent is a fully human monoclonal antibody that inhibits interleukin-4 (IL-4) and interleukin-13 (IL-13) signaling pathways and is not an immunosuppressant. The Dupixent development program has demonstrated clinical benefit and decreased type 2 inflammation in phase 3 trials, establishing that IL-4 and IL-13 are key and central drivers of type 2 inflammation that it plays an important role in multiple related diseases and often co-morbid diseases.
These conditions include approved indications for Dupixent, such as atopic dermatitis, asthma, and chronic rhinosinusitis with nasal polyposis (CRSwNP), as well as investigational diseases prurigo nodularis and eosinophilic esophagitis (EoE) in the EU.
Dupixent has received regulatory approvals for use in certain patients with atopic dermatitis, prurigo nodularis, asthma, CRSwNP, or EoE in different age populations. Dupixent is currently approved for these indications in the US and for one or more of these indications in more than 60 countries, including the EU and Japan. More than 500,000 patients have been treated with Dupixent worldwide.
Dupilumab Development Program
Dupilumab is being jointly developed by Sanofi and Regeneron under a global collaboration agreement. To date, dupilumab has been studied in more than 60 clinical trials involving more than 10,000 patients with a variety of chronic diseases caused in part by type 2 inflammation.
In addition to the currently approved indications, Sanofi and Regeneron are studying dupilumab in a wide range of diseases caused by type 2 inflammation or other allergic processes in phase 3 trials, including pediatric EoE, atopic dermatitis of the hands and feet, chronic inducible urticaria cold, chronic spontaneous urticaria, chronic pruritus of unknown origin, chronic obstructive pulmonary disease with evidence of inflammation type 2, chronic rhinosinusitis without nasal polyposis, allergic fungal rhinosinusitis, allergic bronchopulmonary aspergillosis, and bullous pemphigoid.
These potential uses of dupilumab are currently under clinical investigation, and no regulatory authority has fully evaluated safety and efficacy in these conditions.