FDA Approves Dupilumab (Dupixent) for Eczema

Disclosures

March 28, 2017

The US Food and Drug Administration (FDA) today approved dupilumab (Dupixent, Regeneron Pharmaceutics), a biologic for patients with moderate to severe atopic dermatitis — also called eczema — that spares them from the need to resort to higher-risk systemic immunosuppressants.

The drug's wholesale cost for a year of treatment is $37,000, but discounts, rebates, and patient assistance programs will reduce it, according to a Regeneron news release.

Dupilumab is indicated specifically for adults with moderate to severe eczema who should not use topical corticosteroids or who cannot control their condition adequately with them, the FDA stated in a news release. The drug, administered as an injection under the skin, can be used with or without such topical therapies.

A monoclonal antibody, dupilumab works by binding to a type-2 cytokine that causes inflammation, blocking the inflammatory response involved in eczema.

In three placebo-controlled clinical trials establishing the efficacy of dupilumab, patients with moderate to severe eczema had a characteristic itchy rash covering roughly half of their body surface. Topical corticosteroids may not control such a widespread outbreak, and although systemic immunosuppressants such as cyclosporine are more effective, they come with serious adverse events, such as a higher risk for infections, certain types of cancer, and kidney damage.

Clinical trial participants who received dupilumab achieved clear or almost clear skin and experienced less itchiness after 16 weeks of treatment. Injection site reactions, oral cold sores, and conjunctivitis were among the most common adverse events observed.

The FDA approved dupilumab under its Priority Review and Breakthrough Therapy programs.

The agency cautions clinicians that the drug's safety and efficacy have not been established for treating asthma, experienced by many patients with eczema. "Patients who also have asthma should not adjust or stop their asthma treatment without talking to their physicians," the FDA stated.

More information about today's decision is available on the FDA website.

Follow Robert Lowes on Twitter @LowesRobert

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