After FDA, EU Approves Dupixent for Eczema in Adolescents

Sanai and Regeneron develop Dupixent (dupilumab) for treating moderate-to-severe eczema in adolescents.

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Dupixent (Dupilumab) is a medication developed by Sanofi and Regeneron, which has got regulatory approval in Europe for the treatment of moderate-to-severe eczema in adolescents.

On Tuesday, Sanofi and Regeneron said, “European Commission has extended the marketing authorization for Dupixent in the European Union (EU) to include adolescents 12 to 17 years of age with moderate-to-severe atopic dermatitis who are candidates for systemic therapy.”

Chief Scientific Officer of Regeneron George Yancopoulos said, “Adolescents with moderate-to-severe atopic dermatitis in the EU now have an approved biologic medicine that can significantly control persistent, debilitating symptoms such as itch and skin lesions, as well as improve sleep, which is particularly critical during these formative years.”

In March, the U.S. Food and Drug Administration (FDA) approved Dupixent for atopic dermatitis in people between the ages of 12 and 17.

Last month, Sanofi reported an increase in Dupixent’s sales after the company posted strong second-quarter results.

Some of the most common side effects of Dupixent included injection site reactions – such as redness, swelling and itching. Other side effects were eye inflammation, throat pain, and cold sores.

Also called eczema, atopic dermatitis often leads to skin irritations and itching. Eczema is a long-standing inflammatory disease in which a person experiences the symptoms of skin rash and itching. In moderate-to-severe atopic dermatitis, the skin rashes potentially cover much of the body, along with symptoms of persistent and intense itching, lesions, redness, dryness, cracking, crusting and oozing. Itching is the most troublesome symptom of atopic dermatitis.