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FDA Approves Eczema Injectable After Study

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FDA Approves Dupilumab (Dupixent) for Eczema

The U.S. Food and Drug Administration (FDA) has approved Dupixent (dupilumab) injections for the treatment of adults with moderate-to-severe eczema. This injectable is intended to be used for patients who can’t control their eczema through topical treatments or where topical treatments aren’t advised.

How it Works

Clinical studies were established in three placebo-controlled clinical trials with 2,119 adult participants with moderate or severe eczema. After 16 weeks of treatment, individuals who received the drug saw clear or almost clear skin and a reduction in itch. 

The injection contains an antibody (dupilumab) that binds to a protein receptor [interleukin-4 (IL-4) alpha subunit (IL-4Ra)], which causes inflammation. The binding inhibits the inflammatory response that is common in eczema

“FDA’s approval of Dupixent demonstrates our commitment to approving new and innovative therapies for patients with skin disease. Eczema can cause significant skin irritation and discomfort for patients, so it is important to have a variety of treatment options available, including those patients whose disease is not controlled by topical therapies," said Julie Beitz, M.D., director of the Office of Drug Evaluation III in the FDA's Center for Drug Evaluation and Research.

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