Expanded approval of Dupixent scratches an unmet itch

By Maggie Lynch

- Last updated on GMT

(Image: Getty/Zinkevych)
(Image: Getty/Zinkevych)

Related tags Fda eczema atopic dermatitis Monoclonal antibodies Monoclonal antibody

The FDA approves targeted biologic, Dupixent, for the treatment of atopic dermatitis in patients 12 to 17 years old, the first treatment of its kind for adolescents.

Dupixent (dupilumab), developed in a collaboration between Regeneron Pharmaceuticals and Sanofi,​ has already been approved for the treatment of asthma​ and atopic dermatitis​ in adults, but with this expanded approval is indicated for adolescents as well.

John Reed, head of research and development at Sanofi said in a statement that this expanded approval of the monoclonal antibody (mAb) treatment enables a larger population of patients, “access to a first-of-its-kind biologic treatment that has already been used to treat approximately 50,000 patients in the US.”

Dupixent, a subcutaneous injection, was evaluated under priority review from the US Food and Drug Administration (FDA) and was granted a Breakthrough Therapy designation as well.

The biologic inhibits signals of interleukin-4 and interleukin-13, two proteins that affect type 2 inflammation, an underlying cause of dermatitis and other allergic diseases.

George D. Yancopoulos, chief scientific officer at Regeneron stated that Dupixent may be a potential treatment outside of this expanded indication. “Given that Dupixent targets a key pathway in type 2 inflammation, we are also investigating it in a broad development program in patients with other type 2 inflammatory diseases including eosinophilic esophagitis, chronic rhinosinusitis with nasal polyps, where we recently announced positive Phase 3 results and Priority Review of a U.S. regulatory submission, and food and environmental allergies,”​ he said.

Atopic dermatitis is a form of eczema characterized by a burdensome chronic itch caused by inflammation. With this disease rashes can potentially cover the majority of the body and cause lesions, cracking of the skin, and a ‘debilitating itch.’

Data from a Phase III clinical trial demonstrated that 75% of adolescent patients with moderate-to-severe atopic dermatitis treated with Dupixent saw overall disease improvement.

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