FDA Approves 1st drug for moderate and severe eczema cases

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Thursday, March 30, 2017
FDA Approves 1st drug for moderate and severe eczema cases
A just-approved drug for severe eczema will be available later this week.

WASHINGTON, D.C. (WPVI) -- A just-approved drug for severe eczema will be available later this week.

Dupixent (dupilumab) was fast-tracked by the F-D-A, because it's the first to treat the red, fiercely itchy rash from the inside.

The powerful 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 hayfever common in eczema patients.

It's now in late-stage patient testing as an allergy treatment.

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 4 in 10 had itching decrease sharply, bringing better sleep and reducing anxiety and depression, which affect many patients.

Doctors say can take a toll on people.

"They have absenteeism at work, they can have low self-esteem, by having this eruption that people tend to stare at it. they can have anxiety related to it," says Dr. Harold Farber, of Farber Dermatology in Narberth, Pa.

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.

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.

Eczema often begins in young children, and most grow out of it.

For others, 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 give up on health care because of the limited options.

Dermatologists expect a strong push to get the new drug covered by insurance because there are few treatments for serious cases. As of now, the price is 37-thousand dollars.