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Exploratory Data Show Additional Benefits of Vedolizumab in Ulcerative Colitis

New exploratory data published in the New England Journal of Medicine further provide evidence of the benefits of vedolizumab (Entyvio; Takeda), an integrin receptor antagonist, when compared with adalimumab (Humira; AbbVie), a tumor necrosis factor-alpha (TNFα) antagonist, in patients with moderately to severely active ulcerative colitis.   In the phase 3b VARSITY study, patients were randomized…
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Dupilumab Safe, Effective in Pediatric Atopic Dermatitis Trial

Topline results from a phase 3 study investigating dupilumab in the treatment of pediatric patients with severe atopic dermatitis showed that the interleukin-4 receptor alpha antagonist was both safe and effective in this patient population.
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Dupixent Approved for Chronic Rhinosinusitis With Nasal Polyps

The Food and Drug Administration (FDA) has approved Dupixent (dupilumab; Sanofi and Regeneron) as an add-on maintenance treatment in adult patients with inadequately controlled chronic rhinosinusitis with nasal polyposis (CRSwNP). The approval was based on data from two phase 3 randomized, double blind, placebo controlled trials (SINUS-24 and SINUS-52) that evaluated the safety and efficacy…
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Dupixent sBLA Gets Priority Review for Chronic Rhinosinusitis With Nasal Polyps Indication

Regeneron and Sanofi announced that the Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for Dupixent (dupilumab) as an add-on maintenance treatment for adults with inadequately controlled severe chronic rhinosinusitis with nasal polyps (CRSwNP). The sBLA included data from two phase 3 randomized, double-blind, placebo-controlled trials (SINUS-24…
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Dupilumab Gets Priority Review for Adolescent Atopic Dermatitis

Dupixent is also being assessed in other allergic/inflammatory conditions, including pediatric atopic dermatitis, pediatric asthma, chronic rhinosinusitis with nasal polyps, eosinophilic esophagitis, grass allergy, and peanut allergy.