FDA Approves Dupilumab Injection for Atopic Dermatitis

The US Food and Drug Administration (FDA) has approved dupilumab (Dupixent) injection to treat adults with moderate-to-severe atopic dermatitis.

Dupilumab is intended for patients whose atopic dermatitis is not controlled adequately by topical therapies, or those for whom topical therapies are not advisable. Dupilumab can be used with or without topical corticosteroids.

"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," said Julie Beitz, MD, FDA's Center for Drug Evaluation and Research, Rockville, Maryland.

Dupilumab is administered as an injection under the skin. The drug binds to interleukin-4 receptor alpha subunit (IL-4Ra) -- a protein that causes inflammation. By binding to this protein, dupilumab is able to inhibit the inflammatory response that plays a role in the development of atopic dermatitis.

The safety and efficacy of dupilumab were established in 3 placebo-controlled studies comprising 2,119 adults with moderate-to-severe atopic dermatitis not adequately controlled by topical medication(s).

Overall, patients who received dupilumab achieved greater response -- defined as clear or almost clear skin -- and experienced a reduction in itch after 16 weeks of treatment.

Dupilumab 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 healthcare 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 dupilumab 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 dupilumab Priority Review and Breakthrough Therapy designation.

SOURCE: US Food and Drug Administration