Sanofi and Regeneron’s Dupixent accepted for EU regulatory review

Sanofi and Regeneron Pharmaceuticals' new treatment for atopic dermatitis has been accepted for review by the European Medicines Agency.

A marketing authorisation application for the new drug Dupixent has been accepted by the regulator, which will now assess its suitability for the treatment of adults with moderate-to-severe atopic dermatitis who are candidates for systemic therapy.

The investigational biologic therapy works by inhibiting signalling of IL-4 and IL-13, two key cytokines required for the type 2 immune response, which is believed to be a major driver in the pathogenesis of this disease.

Data from three phase III pivotal studies in the global LIBERTY AD study programme has demonstrated the safety and efficacy of the drug among more than 2,500 patients, and was used to support this regulatory filing.

Dupixent was also accepted for priority review by the US Food and Drug Administration in September. If approved, it will be jointly commercialised by Regeneron and Genzyme, the specialty care global business unit of Sanofi.

The drug is also being studied in paediatric atopic dermatitis, asthma, nasal polyposis and eosinophilic oesophagitis.

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