First biologic medicine approved for adults with moderate-to-severe atopic dermatitis

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Sanofi and Regeneron Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) approved Dupixent® (dupilumab) Injection, 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. Dupilumab comes in a pre-filled syringe and can be self-administered as a subcutaneous injection every other week after an initial loading dose. Dupilumab 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. Dupilumab 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. The approval of Dupilumab was based on data from the global LIBERTY AD clinical program, which included three randomized Phase 3 pivotal trials known as SOLO 1, SOLO 2 and CHRONOS (enrolled 2,119 total adult patients).  The studies examined the use of Dupilumab either alone (SOLO 1 or SOLO 2, 1,379 adult patients enrolled) or with topical corticosteroids (CHRONOS, 740 adult patients enrolled) in patients with inadequately controlled moderate-to-severe AD. In all these studies, Dupilumab alone or with topical corticosteroids met the primary and key secondary endpoints. The most common adverse events that were noted to be greater than or equal to one percent with Dupilumab treatment included injection site reactions, eye and eye lid inflammation including redness, swelling, and itching, and cold sores in the mouth or on the lips. In December 2016, the European Medicines Agency accepted for review Sanofi’s and Regeneron’s marketing authorization application (MAA) for Dupilumab for adults with uncontrolled moderate-to-severe AD.

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