FDA Approves First Drug for Moderate and Severe Eczema Cases

The Malta Independent

April 20, 2017

U.S. regulators have approved the first powerful, injected medicine to treat serious cases of the skin condition eczema.

The Food and Drug Administration on Tuesday approved Dupixent for moderate or severe eczema, which causes red, fiercely itchy rashes on the face, arms and legs.

In three studies of the drug including a total of 2,119 participants, one-third to two-thirds achieved clear or nearly clear skin after 16 weeks of treatment. About four in 10 had itching decrease sharply, bringing better sleep and reducing anxiety and depression, which affect many patients.

Dupixent will have an initial list price of $37,000 per year, according to Paris, France-based Sanofi SA and Regeneron Pharmaceuticals of Tarrytown, New York, which developed the drug.

Side effects can include cold sores and inflammation of the eye and eyelid.

The drug is an antibody that patients inject just under the skin every two weeks. It binds to a specific protein to inhibit the immune system’s inflammatory response. That’s why in many study participants, Dupixent also improved the asthma and hay fever common in eczema patients. It’s now in late-stage patient testing as an allergy treatment.

Eczema treatments have generally been limited to topical medications, steroid creams, moisturizers and ultraviolet light, plus antihistamines to relieve itching. Those work fairly well for mild eczema, but not the severe—and most common—form, also called atopic dermatitis.

Because of that, analyst Jeffrey Holford of Jefferies LLC wrote Tuesday that “market expectations for Dupixent are high given the unmet need in this patient group,” with sales expected to climb slowly to about $3.4 billion in 2025.

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