FDA Approves New Eczema Drug Dupixent

Tuesday, March 28, 2017 | FDA Approval/Clearance , Atopic Dermatitis , Regeneron , Sanofi


The FDA has approved Dupixent (dupilumab) injection to treat adults with moderate-to-severe eczema (atopic dermatitis). Regeneron Pharmaceuticals, Inc.'s Dupixent is intended for patients whose eczema is not controlled adequately by topical therapies, or those for whom topical therapies are not advisable. Dupixent can be used with or without topical corticosteroids.

Dupixent is a human monoclonal antibody that is designed to specifically inhibit overactive signaling of two key proteins, IL-4 and IL-13, which are believed to be major drivers of the persistent underlying inflammation in AD. Dupixent comes in a pre-filled syringe and can be self-administered as a subcutaneous injection every other week after an initial loading dose. Dupixent can be used with or without topical corticosteroids. It should not be used in patients who are allergic to dupilumab or any of the ingredients in Dupixent.

The safety and efficacy of Dupixent were established in three placebo-controlled clinical trials with a total of 2,119 adult participants with moderate-to-severe atopic dermatitis not adequately controlled by topical medication(s). Overall, participants who received Dupixent achieved greater response, defined as clear or almost clear skin, and experienced a reduction in itch after 16 weeks of treatment.

Dupixent can cause side effects such as serious allergic reactions and eye problems, such as pink eye (conjunctivitis) and inflammation of the cornea (keratitis). If patients experience new or worsening eye symptoms such as redness, itching, pain or visual changes, they should consult a health care provider. 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 safety and efficacy of Dupixent have not been established in the treatment of asthma. Patients who also have asthma should not adjust or stop their asthma treatment without talking to their physicians.

DUPIXENT was evaluated by the FDA with Priority Review, which is reserved for medicines that represent potentially significant improvements in safety or efficacy in treating serious conditions.

"FDA's approval of Dupixent demonstrates our commitment to approving new and innovative therapies for patients with skin disease," said Julie Beitz, MD, director of the Office of Drug Evaluation III in the FDA's Center for Drug Evaluation and Research. "Eczema can cause significant skin irritation and discomfort for patients, so it is important to have a variety of treatment options available to patients, including those patients whose disease is not controlled by topical therapies."

Regeneron and Sanofi Genzyme, the specialty care global business unit of Sanofi, will market Dupixent in the United States. Dupixent is expected to be available to patients and providers in the in the next week.

Regeneron and Sanofi recognize that Dupixent can only help those uncontrolled moderate-to-severe AD patients that were prescribed the medicine if they can both access the medicine and use it properly. Therefore, the companies have launched DUPIXENT MyWay, a comprehensive and specialized program that provides support and services to patients throughout every step of the treatment process. 

DUPIXENT MyWay will help eligible patients who are uninsured, lack coverage, or need assistance with their out-of-pocket costs. Additionally, DUPIXENT MyWay offers personalized support from registered nurses and other specialists who are available 24/7 to speak with patients and help them navigate the complex insurance process. For more information,  visit www.DUPIXENT.com.

 

 

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