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US FDA approval for Dupixent, targeted biologic therapy for atopic dermatitis


Dupixent will be available later this week to the US patients suffering from this chronic and debilitating form of eczema

Sanofi and Regeneron Pharmaceuticals have announced that the US Food and Drug Administration (FDA) approved Dupixent (dupilumab) Injection, reportedly the first and only biologic medicine approved for the treatment of adults with moderate-to-severe atopic dermatitis (AD) whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable.

Dupixent is a human monoclonal antibody that is designed to specifically inhibit overactive signaling of two key proteins, IL-4 and IL-13, which are believed to be major drivers of the persistent underlying inflammation in AD. Dupixent comes in a pre-filled syringe and can be self-administered as a subcutaneous injection every other week after an initial loading dose. Dupixent can be used with or without topical corticosteroids. It should not be used in patients who are allergic to dupilumab or any of the ingredients in Dupixent.

Dupixent was evaluated by the FDA with Priority Review, which is reserved for medicines that represent potentially significant improvements in safety or efficacy in treating serious conditions. This followed the FDA’s 2014 Breakthrough Therapy designation for Dupixent for inadequately controlled moderate-to-severe AD. Breakthrough Therapy designation was created by the FDA to expedite the development and review of drugs developed for serious or life-threatening conditions/ Dupixent represents the first time this designation was granted for a dermatological disease, other than in dermatologic cancers.

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

Sanofi and Regeneron have also launched Dupixent MyWay, a comprehensive and specialised programme to provide support and services to patients throughout every step of the treatment process. Dupixent MyWay will help eligible patients who are uninsured, lack coverage, or need assistance with their out-of-pocket costs.

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