Sanofi and Regeneron announce positive Phase 3 results for dupilumab and plan FDA application

Biosimilar News

On April 1, Sanofi and Regeneron announced positive results in two placebo-controlled Phase 3 studies of dupilumab, a monoclonal antibody under evaluation for the treatment of adult patients with inadequately controlled moderate-to-severe atopic dermatitis.  According to Sanofi’s and Regeneron’s press release:  “There are no approved systemic therapies in the U.S. for people with moderate-to-severe atopic dermatitis,” and “[t]hese are the first Phase 3 studies of a systemic therapy to demonstrate a significant improvement in moderate-to-severe atopic dermatitis, a chronic, debilitating inflammatory disease that impacts over one million Americans.”  Sanofi has indicated that it plans to submit a regulatory application to the FDA in the third quarter of this year.

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