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The U.S. FDA ‘gave-a-go’ to a New Drug Dupixent for treating Eczema

Apr 11, 2017

The U.S. FDA ‘gave-a-go’ to a New Drug Dupixent for treating Eczema

On Tuesday, the United States Food and Drug Administration gave a nod to a new drug meant for the treatment of moderate-to-severe eczema (atopic dermatitis) in adults.

The drug called Dupixent (dupilumab) is an injection which has to be taken twice a month under the skin. The drug is specifically meant for patients who have tried all possible topical therapies for eczema and have failed, and also for patients who are intolerant towards topical treatments. Dupixent drug can be used either with or without topical corticosteroids.

Patients can self-administer the injection at home and the treatment is estimated to cost $37,000 a year. However the drug manufacturers Sanofi and Regeneron Pharmaceuticals have emphasized that the costing is a wholesale price and there would probably be programs to assist patients pay for it.

It is exclusively approved for individuals suffering from severe atopic dermatitis which is a term used for scaly and itchy skin caused by allergy. The condition can be extremely unpleasant.

According to the FDA, a combination of immune, genetic, and environmental factors lead to atopic dermatitis. The skin develops crusted and scaly red bumps that are excessively itchy. Scratching will result in cracking, swelling, and secretion of clear fluid and thickening of the skin.

 

There are several treatments available presently, ranging from immune suppressant drugs like tacrolimus, skin lotions to steroidal creams. However, not necessarily everyone benefits from these available options; in fact immune suppressant drugs could elevate the risk of cancers such as lymphoma.

Dupixent is a monoclonal antibody, which is a targeted immune system drug. This drug demobilizes two inflammatory components known as interleukin 4 or IL-4, and IL-13. In a statement the FDA said, "By binding to this protein, Dupixent is able to inhibit the inflammatory response that plays a role in the development of atopic dermatitis."

The generic term for this drug is called dupilumab, and it can potentially lead to eye inflammation and severe allergic reaction. The most common side effects would be cold sores in lips or mouth, injection site reactions; eyes could get red along with swelling and itching.

The agency rendered both the path-breaking therapy status and priority review, thereby fastening the approval process.

In a study comprising of 2,000 individuals demonstrated Dupixent injections lead to clearer skin for nearly 2/3rds of those who tried it and decrease the intensity of itchiness by almost 40 percent.

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

Manufacturer Regeneron mentioned, "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."

In an approval to the sensitiveness and concern regarding the prices of the drug, the company has accentuated that there is no single price for the drug at present.

In a press statement, the company said, "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."

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