New Eczema Drug Dupixent wins FDA Approval

The Food and Drug Administration approved a new drug on Tuesday to treat serious cases of eczema.

The drug, called Dupixent, is a twice-a-month injection under the skin. Patients can do it at home. It'll cost $37,000 a year but the drug's makers, Regeneron Pharmaceuticals and Sanofi, have stressed that's the wholesale price and make a point of saying there will be programs to help people pay for it.

It's approved for people with atopic dermatitis, a catchall term for itchy skin caused by allergy.

"The cause of atopic dermatitis is a combination of genetic, immune and environmental factors. In atopic dermatitis, the skin develops red, scaly and crusted bumps, which are extremely itchy," the FDA says.

"Scratching leads to swelling, cracking, weeping clear fluid, and finally, coarsening and thickening of the skin."

There are many treatments out there now, from simple skin lotions to steroid creams and immune suppressant drugs like tacrolimus. But none of these works for everybody, and the immune suppressant drugs can raise the risk of cancers such as lymphoma.

"“People with moderate to severe atopic dermatitis cope with intense, sometimes unbearable symptoms that can impact them for most of their lives.”"

Dupixent is for the hard-core cases that aren't helped by anything else.

It's a monoclonal antibody — a targeted immune system drug — that inactivates two inflammatory compounds called interleukin 4 or IL-4, and IL-13. "By binding to this protein, Dupixent is able to inhibit the inflammatory response that plays a role in the development of atopic dermatitis," the FDA said in a statement.

Known generically as dupilumab, the drug can cause serious allergic reactions and eye inflammation. "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 FDA notes.

Studies of about 2,000 people showed Dupixent injections resulted in clear skin or nearly clear skin for about two-thirds of those who tried it, and it reduced itching sharply in 40 percent.

"People with moderate to severe atopic dermatitis cope with intense, sometimes unbearable symptoms that can impact them for most of their lives," Julie Block, president and CEO of the National Eczema Association, said in a statement provided by the company.

"Of the adults with uncontrolled moderate to severe atopic dermatitis in the United States, it is estimated that 300,000 are most in need of new treatment options," Regeneron said.

In a nod to the sensitivity around drug prices, the company stressed that there is no single price for the drug.

"The Wholesale Acquisition Cost (WAC) of Dupixent in the United States is $37,000 annually. Actual costs to patients, payers and health systems are anticipated to be lower as WAC pricing does not reflect discounts, rebates or patient assistance programs," it said.

Mar 28 2017


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