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Regeneron Pharmaceuticals Inc wins US FDA approval for Dupixent to treat moderate-to-severe atopic dermatitis.

Global Banking News-March 13, 2019-Regeneron Pharmaceuticals Inc wins US FDA approval for Dupixent to treat moderate-to-severe atopic dermatitis

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Biotechnology company Regeneron Pharmaceuticals Inc (NASDAQ:REGN) and Sanofi Tuesday jointly announced on Tuesday that the US Food and Drug Administration (FDA) has approved Dupixent for the treatment of adolescent patients with moderate-to-severe atopic dermatitis under its priority review and breakthrough therapy designation.

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

The partnership disclosed that the US Food and Drug Administration (FDA) has authorised Dupixent (dupilumab) for adolescent patients 12 to 17 years of age with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. Dupixent comes in two doses (200 mg and 300 mg), each as a pre-filled syringe.

Dupixent, which can be used with or without topical corticosteroids, is a targeted biologic therapy that inhibits signaling of interleukin-4 (IL-4) and interleukin-13 (IL-13), two key proteins that may play a central role in type 2 inflammation that underlies atopic dermatitis and several other allergic diseases added the companies.

Under the partnership's pivotal Phase 3 trial that evaluated Dupixent monotherapy in adolescent patients with uncontrolled moderate-to-severe atopic dermatitis, the safety and efficacy were generally consistent with that previously seen in adult studies. At 16 weeks, about 24% of patients who received Dupixent achieved clear or almost clear skin compared to 2% with placebo, as measured by an Investigator's Global Assessment (IGA) score of 0 or 1, the primary endpoint of the trial.

((Distributed via M2 Communications -

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Publication:Global Banking News (GBN)
Date:Mar 13, 2019
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