"The U.S. Food and Drug Administration today approved Dupixent dupilumab injection to treat adults with moderatetosevere eczema atopic dermatitis. 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. FDAs approval of Dupixent demonstrates our commitment to approving new and innovative therapies for patients with skin disease said Julie Beitz M.D. director of the Office of Drug Evaluation III in the FDAs 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. Atopic dermatitis a chronic inflammatory skin disease is often referred to as eczema which is a general term for several types of inflammation of the skin. Atopic dermatitis is the most common of the many types of eczema onset typically begins in childhood and can last through adulthood. 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. Scratching leads to swelling cracking weeping clear fluid and finally coarsening and thickening of the skin. Dupixent is administered as an injection under the skin. Dupixents active ingredient is an antibody dupilumab that binds to a protein interleukin IL receptor alpha subunit ILRa that causes inflammation. By binding to this protein Dupixent is able to inhibit the inflammatory response that plays a role in the development of atopic dermatitis. The safety and efficacy of Dupixent were established in three placebocontrolled clinical trials with a total of  adult participants with moderatetosevere atopic dermatitis not adequately controlled by topical medications. Overall participants who received Dupixent achieved greater response defined as clear or almost clear skin and experienced a reduction in itch after  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. The FDA granted the application for Dupixent Priority Review https and Breakthrough Therapy https designation. The FDA granted the approval of Dupixent to Regeneron Pharmaceuticals Inc. The FDA an agency within the U.S. Department of Health and Human Services protects the public health by assuring the safety effectiveness and security of human and veterinary drugs vaccines and other biological products for human use and medical devices. The Agency also is responsible for the safety and security of our nations food supply cosmetics dietary supplements products that give off electronic radiation and for regulating tobacco products."