Sanofi and Regeneron's eczema drug gets FDA approval

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26 Aug, 2025 12:21

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Global healthcare company Sanofi and Regeneron Pharmaceuticals today announced that the US Food and Drug Administration (FDA) has approved Dupixent (dupilumab) injection to patients suffering from chronic and debilitating form of eczema.

The FDA approved Dupixent (dupilumab), is the first targeted biologic therapy for adults with moderate-to-severe atopic dermatitis. It will be available later this week to US patients suffering from this chronic and debilitating form of eczema, a joint statement issued here said.

"People with moderate-to-severe atopic dermatitis cope with intense, sometimes unbearable symptoms that can impact them for most of their lives," National Eczema Association President and Chief Executive Officer Julie Block said.

"To date, there have been few options available to treat people with moderate-to-severe atopic dermatitis who have uncontrolled disease. Now we have a treatment that is expected to help address patients suffering from this devastating disease," Block said.

Atopic dermatitis (AD), the most common form of eczema, is a chronic inflammatory disease with symptoms often appearing as a rash on the skin.

Moderate-to-severe AD is characterised by rashes often covering much of the body, and can include intense, persistent itching and skin dryness, cracking, redness, crusting, and oozing.

Itch is one of the most burdensome symptoms for patients and can be debilitating. Of the adults with uncontrolled moderate-to-severe AD in the United States, it is estimated that 300,000 are most in need of new treatment options.

"The approval of Dupixent offers new hope for adults with moderate-to-severe AD in the United States, and we look forward to working with regulatory authorities around the world to bring this important new medicine to patients globally," Sanofi Chief Executive Officer Olivier Brandicourt said.

Sanofi Genzyme, the specialty care global business unit of Sanofi, and Regeneron will market Dupixent in the United States.