• Regeneron, Sanofi: Phase 3 Dupixent Trial Meets Primary, Key Secondary Endpoints

    • May 17, 2018
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    Regeneron Pharmaceuticals, Inc. ( REGN ) and French drug giant Sanofi SA (SNY, SNYNF) announced Wednesday that a pivotal Phase 3 trial evaluating Dupixent (dupilumab) to treat moderate-to-severe atopic dermatitis in adolescents met its primary and key secondary endpoints.

    In the trial, treatment with Dupixent as monotherapy significantly improved measures of overall disease severity, skin clearing, itching and certain health-related quality of life measures, the companies noted. Dupixent is the first and only biologic to show positive results in this patient population.

    Patients treated with Dupixent had significant improvement in disease severity at 16 weeks. The primary endpoints were the proportion of patients achieving Investigator’s Global Assessment score of 0 or 1 and 75% improvement in Eczema Area and Severity Index at 16 weeks.

    George Yancopoulos, President and Chief Scientific Officer of Regeneron, said, “Moderate-to-severe atopic dermatitis can place a particularly significant burden on adolescents, who have to deal with oozing skin lesions with unrelenting, intense itching during their formative years. Dupixent blocks the IL-4/IL-13 pathway, which is emerging as a central driver of Type 2 allergic inflammation. We are committed to investigating the potential for Dupixent across Type 2 inflammatory diseases with high unmet need including atopic dermatitis, asthma, eosinophilic esophagitis, nasal polyps, chronic obstructive pulmonary disease, and food allergy.”

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