Sanofi and Regeneron Pharmaceuticals Inc.'s Dupixent injection has been approved by the U.S. Food and Drug Administration (FDA) for use treating adults with moderate-to-severe atopic dermatitis (AD) whose disease is not adequately controlled with topical prescription therapies.
"People with moderate-to-severe atopic dermatitis cope with intense, sometimes unbearable symptoms that can impact them for most of their lives," Julie Block, president and CEO of National Eczema Association, said in a statement. "To date, there have been few options available to treat people with moderate-to-severe atopic dermatitis who have uncontrolled disease. That's why today's approval of Dupixent is so important for our community. Now we have a treatment that is expected to help address patients suffering from this devastating disease."
Dupixent, a human monoclonal antibody, was made to inhibit two proteins believed to drive inflammation in AD. The drug was evaluated by the FDA with priority review, a designation given to drugs with potential to greatly improve efficacy in treating serious conditions. Dupixent is the first and only FDA-approved biologic medicine for its purpose.
"Dupixent is the result of years of tireless research by our scientists into the underlying causes of allergic and atopic diseases," Dr. George D. Yancopoulos, founding scientist, president and chief scientific officer, Regeneron, said in the statement. "In atopic dermatitis, Dupixent was shown to help clear the skin and manage the intense itch caused by the disease. Today's approval would not be possible without the dedication of the clinical investigators and the participation of the patients who took part in the global LIBERTY AD clinical program."
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