FDA Approves Dupixent to Treat Eczema

Active ingredient binds to protein (interleukin-4 receptor alpha subunit) that causes inflammation

fda logo

WEDNESDAY, March 29, 2017 (HealthDay News) -- Dupixent (dupilumab) has been approved by the U.S. Food and Drug Administration to treat moderate-to-severe eczema that isn't well controlled by topical medication.

The active ingredient in Dupixent is an antibody (dupilumab) that binds to a protein (interleukin-4 receptor alpha subunit) that causes inflammation, and is administered subcutaneously. Its effectiveness was evaluated in clinical studies involving 2,119 patients for whom topical medication hadn't worked. Overall, participants who received Dupixent achieved clear or almost clear skin and a reduction in itch after 16 weeks of treatment.

The most common side effects included injection-site reactions, cold sores, and eye inflammation. More serious adverse effects included severe allergic reactions, conjunctivitis, and keratitis.

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

The FDA granted approval of Dupixent to Regeneron Pharmaceuticals.

More Information

Physician's Briefing