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Regeneron, Sanofi's Dupixent gains US FDA approval for eczema in adolescents

Regeneron Pharmaceuticals Inc. and Sanofi received the U.S. Food and Drug Administration's approval for their Dupixent injection to treat adolescent patients with moderate to severe atopic dermatitis.

The drug is now approved to treat 12 to 17 years old patients with moderate to severe atopic dermatitis, the most common form of eczema, when the disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. Atopic dermatitis is a chronic inflammatory disorder that causes rashes.

Dupixent, already approved in the U.S. to treat certain adults with moderate to severe atopic dermatitis and as an add-on maintenance therapy for moderate to severe asthma, inhibits signaling of two types of proteins that cause inflammation in atopic dermatitis and other allergic diseases.

The U.S. FDA evaluated the drug under priority review, and its approval for treating adolescents is based on results from a late-stage study in adolescents with moderate to severe atopic dermatitis.

Most recently, the FDA granted a priority review to Dupixent as an add-on maintenance treatment for adults with inadequately controlled severe chronic rhinosinusitis with nasal polyps, or CRSwNP. CRSwNP is a chronic disease in which a type 2 or allergic inflammation causes nasal polyps — soft, painless, noncancerous growths — that obstruct the sinus and nasal passages.

Tarrytown, N.Y.-based Regeneron and French pharmaceutical company Sanofi are jointly developing the therapy under a global collaboration agreement and are conducting clinical trials for the drug in pediatric atopic dermatitis, pediatric asthma and eosinophilic esophagitis.

The companies also plan to study the drug for treating patients with chronic obstructive pulmonary disease, which is characterized by inflammation in the lungs.