The U.S. Food and Drug Administration approved Dupixent (dupilumab) injection to treat adults with moderate–to–severe eczema. Dupixent is intended for patients whose eczema is not controlled adequately by topical therapies, or those for whom topical therapies are not advisable. Dupixent can be used with or without topical corticosteroids. Dupixent is administered as an injection under the skin. Dupixent’s active ingredient is an antibody (dupilumab) that binds to a protein [interleukin–4 (IL–4) receptor alpha subunit (IL–4Ra)], that causes inflammation. By binding to this protein, Dupixent is able to inhibit the inflammatory response that plays a role in the development of atopic dermatitis.

The safety and efficacy of Dupixent were established in three placebo–controlled clinical trials with a total of 2,119 adult participants with moderate–to–severe atopic dermatitis not adequately controlled by topical medications. Overall, participants who received Dupixent achieved greater response, defined as clear or almost clear skin, and experienced a reduction in itch after 16 weeks of treatment.

Dupixent can cause side effects such as serious allergic reactions and eye problems, such as conjunctivitis and keratitis. If patients experience new or worsening eye symptoms such as redness, itching, pain or visual changes, they should consult a health care provider. The most common side effects include injection site reactions; cold sores in the mouth or on the lips; and eye and eyelid inflammation, including redness, swelling and itching.

The safety and efficacy of Dupixent have not been established in the treatment of asthma. Patients who also have asthma should not adjust or stop their asthma treatment without talking to their physicians.

The FDA granted the application for Dupixent Priority Review and Breakthrough Therapy designation.

The FDA granted the approval of Dupixent to Regeneron Pharmaceuticals, Inc.