EU regulator clears Sanofi, Regeneron's Dupixent for atopic dermatitis

Sanofi and Regeneron Pharmaceuticals announced Thursday that the European Commission approved Dupixent (dupilumab), for use in adults with moderate-to-severe atopic dermatitis who are candidates for systemic therapy. The clearance comes after the European Medicines Agency's Committee for Medicinal Products for Human Use adopted a positive opinion in July regarding authorisation of the drug, which inhibits IL-4 and IL-13. 

According to the companies, approval of Dupixent was based on studies from the global LIBERTY AD clinical trial programme, which involved nearly 3000 patients. In all of the trials, which included the SOLO 1 and SOLO 2 studies, as well as CHRONOS, SOLO-CONTINUE and CAFÉ, Dupixent alone or in combination with topical corticosteroids met the primary and key secondary endpoints. 

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In March, the FDA authorised Dupixent for the treatment of adults with moderate-to-severe atopic dermatitis that is not well controlled with prescription therapies used on the skin, or who cannot use topical therapies. Analysts expect the product to generate annual sales of 4.7 billion euros ($5.5 billion) by 2023.

Earlier this month, Sanofi and Regeneron reported that a Phase III study of dupilumab in a broad population of patients with uncontrolled, persistent asthma met its two primary endpoints. The companies indicated that they plan to submit a filing to the FDA by the end of this year seeking approval of the therapy in this indication. Dupilumab is also being studied in other inflammatory diseases that are believed to be driven by the IL-4/IL-13 pathway, including nasal polyposis and eosinophilic esophagitis.

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