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  • 3/1/19 8:19 am EST
    PARIS and TARRYTOWN, NY--

    The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for  Dupixent® (dupilumab), recommending its approval in the European Union for use in adults and adolescents 12 years and older as add-on maintenance treatment for severe asthma with type 2 inflammation characterized by raised blood eosinophils and/or raised FeNO who are inadequately controlled with high dose inhaled corticosteroid plus another medicinal product for maintenance treatment.

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  • 3/1/19 7:02 am EST
    CAMBRIDGE, MA and TARRYTOWN, NY--

    A diverse set of clinical and real-world data will be presented at the 2019 American Academy of Dermatology (AAD) Annual Meeting from March 1 to 5 in Washington, D.C.

    “The data presented at AAD 2019 build upon the established body of knowledge around the efficacy and safety of Dupixent, which has been used to treat nearly 50,000 patients with inadequately controlled moderate-to-severe atopic dermatitis since its approval nearly two years ago,” said Neil Graham, M.D., Vice President of Program Direction at Regeneron.

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  • 2/25/19 12:46 pm EST
    PARIS and TARRYTOWN, NY--

    Detailed results were presented from two Phase 3 trials in adults with recurring severe chronic rhinosinusitis with nasal polyps (CRSwNP) despite previous treatment with surgery and/or systemic corticosteroids. These trials, known as SINUS-24 and SINUS-52, demonstrated that Dupixent® (dupilumab), when added to the standard of care corticosteroid nasal spray,  improved nasal polyp size, nasal congestion severity, chronic sinus disease, sense of smell and co-morbid asthma outcomes.

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  • 2/7/19 9:46 am EST
    Cambridge, MA--

    Results from multiple studies of the investigational therapy avalglucosidase alfa in patients with Pompe disease were presented this week during the 15th Annual WORLDSymposium™ in Orlando, Florida. Pompe disease is a progressive, debilitating and often fatal neuromuscular disease that affects an estimated 50,000 people worldwide.  It can occur at any age from infancy to late adulthood.

    NEO-EXT: Ongoing extension study of the Phase 1/2 trial

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  • 2/6/19 12:12 pm EST
    Paris--

    The U.S. Food and Drug Administration (FDA) has approved Cablivi® (caplacizumab-yhdp) in combination with plasma exchange and immunosuppression for the treatment of acquired thrombotic thrombocytopenic purpura (aTTP) in adults.  Cablivi is the first FDA approved therapy specifically indicated for the treatment of aTTP.

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  • 2/5/19 7:02 am EST
    Paris--

    The pivotal Phase 3 trial of isatuximab in patients with relapsed/refractory multiple myeloma met the primary endpoint of prolonging progression free survival in patients treated with isatuximab in combination with pomalidomide and low-dose dexamethasone versus pomalidomide and low-dose dexamethasone alone (standard of care).

    Results will be submitted to an upcoming medical meeting and are anticipated to form the basis of regulatory submissions planned for later this year.

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  • 1/30/19 7:27 am EST
    Cambridge, MA--

    Continued research and development is critical to advancing care for people with rare diseases who have a significant need for earlier diagnosis, better disease management opportunities, and new treatment options. Sanofi Genzyme, the specialty care global business unit of Sanofi, has been a pioneer in rare diseases with a focus on lysosomal diseases, a group of extremely rare genetic diseases, for more than three decades.

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  • 1/9/19 5:05 pm EST
    Paris--

    The New England Journal of Medicine (NEJM) today published positive results of the Phase 3 trial of Cablivi® (caplacizumab) in adults with acquired thrombotic thrombocytopenic purpura (aTTP).

    aTTP is a rare, life-threatening autoimmune blood disorder characterized by extensive clot formation in small blood vessels throughout the body, leading to severe thrombocytopenia (very low platelet count), microangiopathic hemolytic anemia (loss of red blood cells through destruction), ischemia (restricted blood supply to parts of the body) and widespread organ damage, especially in the brain and heart.

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  • 11/29/18 7:05 am EST
    Bridgewater, NJ--

    Some of the most serious unmet patient needs today are in the field of hematology. Rare blood disorders and blood-related cancers continue to be a major focus of research as scientists look for new treatments for serious and life-threatening conditions.

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  • 11/6/18 7:00 am EST
    PARIS and TARRYTOWN, NY--

    The U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for Dupixent® (dupilumab) in adolescent patients 12 to 17 years of age with moderate-to-severe atopic dermatitis, whose disease was inadequately controlled with topical therapies or for whom topical treatment was medically inadvisable. Currently, there are no FDA-approved systemic biologic medicines to treat adolescents with moderate-to-severe atopic dermatitis. The target action date for the FDA decision is March 11, 2019.

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