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Sanofi and Regeneron’s atopic dermatitis drug secures FDA priority review

pharmafile | September 26, 2016 | News story | Research and Development, Sales and Marketing  

Regeneron and Sanofi have announced that the US Food and Drug Administration has granted priority review for the pair’s atopic dermatitis (AD) treatment dupilumab.

The drug has been accepted under the indication of treatment in adults of inadequately controlled moderate-to-severe AD, a serious, chronic inflammatory skin disease. The investigational antibody therapy inhibits signaling of IL-4 and IL-13, two key cytokines required for the type 2 (including Th2) immune response, which is believed to be a major driver in the pathogenesis of the disease.  

The drug was accepted on the basis of data from three Phase III studies in the global LIBERTY AD programme comprising more than 2,500 patients and evaluating dupilumab as monotherapy and in concomitant administration with topical corticosteroids.

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The FDA granted Breakthrough Therapy designation to the drug for the treatment of adults with moderate-to-severe AD who are not adequately controlled with topical prescription therapies.

Matt Fellows

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