FDA Approves 1st Drug for Moderate & Severe Eczema Cases

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. About 4 in 10 had itching decrease sharply, bringing better sleep and reducing anxiety and depression.

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.

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 form, also called atopic dermatitis. It’s also the most common form.

Eczema often begins in young children, and most grow out of it, said Dr. Lisa Beck, a dermatology professor at the University of Rochester Medical Center in Rochester, New York.

But for other patients, the condition persists throughout adulthood, tormenting patients with relentless itching that triggers scratching, and with that, skin swelling, cracking, “weeping” of clear fluid and, eventually, thickening of the skin, according to the FDA.

“Many of these patients gave up on health care because we offered them nothing new for years and years,” said Beck, a member of the National Eczema Association’s scientific advisory board who participated in patient tests of Dupixent, also called dupilumab.

The drug is an antibody that’s injected just under the skin. It works by binding to a specific protein to inhibit the immune system’s inflammatory response.