NAPSR News: Regeneron & Sanofi's Dupilumab Receives Breakthrough Therapy Designation From FDA

WASHINGTON - Nov. 20, 2014 - PRLog -- Sanofi and Regeneron’s investigational therapy, Dupilumab has received the Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for the treatment of adults with moderate-to-severe atopic dermatitis (AD) who are unresponsive and/or not effectively controlled by other prescribed topical medications. Dupilumab is a fully-human monoclonal antibody and works by blocking two cytokines, IL-4 and IL-13 essential for the Th2 (Type 2 helper T-cell) immune response, which is theoretically known to be a critical pathway in allergic inflammation.

The Breakthrough Therapy Designation was assigned based on results from a Phase 1 and Phase 2 clinical trials. A phase 3 clinical study is currently underway to assess dupilumab in adults with moderate-to-severe atopic dermatitis. For more information, please visit http://clinicaltrials.gov. The Breakthrough Therapy Designation is intended to accelerate the development and review process for drugs designed to treat serious or life threatening condition.

“Moderate to severe atopic dermatitis is a debilitating, life-altering disease with very limited treatment options. Many patients suffer for years with widespread inflamed skin, debilitating itch, sleep disturbances and other challenges,” said Julie Block, Chief Executive Officer, National Eczema Association. “We are thrilled to see that FDA recognizes the need to expedite and prioritize potential new options for these patients.”

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