FDA approves new indication for Regeneron, Sanofi’s Dupixent

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FDA approves new indication for Regeneron, Sanofi’s Dupixent

By Sandra Levy - 03/13/2019
The Food and Drug Administration has approved a new indication for Regeneron and Sanofi's Dupixent (dupilumab). The drug now is approved for use in adolescent patients age 12-to-17 years old with moderate to severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable. Dupixent can be used with or without topical corticosteroids.

"For the first time, adolescents with uncontrolled moderate to severe atopic dermatitis have an approved biologic treatment option to help control persistent, often debilitating symptoms, such as chronic itch and widespread rash. Today's approval expands the use of Dupixent in the U.S. to include both adults and adolescents with atopic dermatitis or moderate-to-severe asthma," Regeneron’s president and chief scientific officer George Yancopoulos said.

Dupixent is a targeted biologic therapy that inhibits signaling of interleukin-4 nd interleukin-13, two key proteins that may play a central role in type 2 inflammation that underlies atopic dermatitis and several other allergic diseases.

"The approval of Dupixent for adolescents with moderate to severe atopic dermatitis means that, for the first time, these patients and their families, who often help them manage this debilitating disease, will have access to a first-of-its-kind biologic treatment that has already been used to treat approximately 50,000 patients in the U.S.," Sanofi head of research and development John Reed said. "Our phase 3 data demonstrated that Dupixent treatment significantly improved skin lesions, reduced itching and helped clear the skin of these adolescent patients."

Dupixent comes in a 200-mg and 300-mg dosage, each as a prefilled syringe. Dupixent is intended for injection under the skin and is given every other week following an initial loading dose. It can be given in a clinic or, for convenience, at home by self-administration after training by a healthcare professional.

Dupixent is also approved in the United States for the treatment of adult patients with moderate to severe atopic dermatitis, or eczema, that is not well controlled with prescription therapies used on the skin, or who cannot use topical therapies; and for use with other asthma medicines for the maintenance treatment of moderate-to-severe asthma in people age 12 years old and older whose asthma is not controlled with their current asthma medicines.

In 2016, the FDA granted Breakthrough Therapy designation for Dupixent for the treatment of moderate to severe atopic dermatitis in adolescents age 12-to-17 years old, and severe atopic dermatitis not well controlled on topical prescription medications in children age 6 months to 11 years old.

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