nd mortality within post ACS patient population is being investigated in the ongoing ODYSSEY OUTCOMES trial. In parallel, the ability of Praluent to reduce major cardiovascular events is being investigated and results are anticipated in 2017. Praluent has been approved by both the FDA in the U.S. and the European Commission. As of March 2016, Praluent had been launched in the U.S., Germany, the U.K., Austria and Nordic countries. In August 2015, an application for Praluent was submitted in Japan and submission in the rest of the world is progressing according to plans. The main countries contributing to Praluent sales in 2015 were the U.S. and Germany. Multaq Multaq (dronedarone) is among the most extensively studied anti-arrhythmic drugs in atrial fibrillation (AF) and has demonstrated a cardiovascular outcome benefit in the ATHENA study and effective rhythm control in the EURIDIS and ADONIS studies, which was confirmed in real world investigations. Multaq is a multichannel blocker with anti-arrhythmic (prevention of AF recurrences) properties and is the first and only anti-arrhythmic drug to have shown a reduction in cardiovascular hospitalization and death in patients with paroxysmal and persistent AF. The main countries contributing to Multaq sales in 2015 were the U.S., Germany and Italy. Rare Diseases The company’s Rare Diseases business is focused on products for the treatment of rare genetic diseases and other chronic debilitating diseases, including lysosomal storage disorders, or LSDs, a group of metabolic disorders caused by enzyme deficiencies. Cerezyme Cerezyme (imiglucerase for injection) is an enzyme replacement therapy used to treat Gaucher disease, an inherited, potentially life-threatening LSD. It is estimated that Gaucher disease occurs in approximately 1 in 120,000 newborns in the general population and 1 in 850 in the Ashkenazi Jewish population worldwide, but the incidence and patient severity vary among regions. Cerezyme is the only therapy with a 20-year history of reducing, relieving and reversing many of the symptoms and risks of Type 1 and Type 3 (in certain markets) Gaucher disease. Cerezyme is administered by intravenous infusion over one or two hours. The principal markets for Cerezyme are the U.S., Europe and Latin America. Cerdelga Cerdelga (eliglustat) is the only first-line oral therapy for Gaucher disease Type 1. A potent, highly specific ceramide analogue inhibitor of GL-1 synthesis with tissue distribution, Cerdelga has demonstrated efficacy in the treatment of naïve Gaucher disease patients and in patients who switch from enzyme replacement therapy (ERT). The Cerdelga development program is the largest ever in Gaucher disease, with approximately 400 patients treated in 29 countries. The principal market for Cerdelga is the U.S. It received European Medicines Agency (EMA) approval in January 2015 and was approved in Japan in March 2015. Myozyme/Lumizyme Myozyme/Lumizyme (alglucosidase alfa) are enzyme replacement therapies used to treat Pompe disease, an inherited, progressive and often fatal LSD. Pompe disease occurs in approximately 1 in 40,000 newborns worldwide, but the incidence and patient severity vary among regions. Myozyme has been marketed in the U.S. and the E.U. and is approved in 76 countries. Outside the U.S., Myozyme is marketed for patients with both infantile- and late-onset disease. Lumizyme has been marketed in the U.S. Initially designed specifically to treat patients with late-onset Pompe disease and patients over eight years of age without evidence of cardiac hypertrophy, on August 1, 2014 it was approved for infantile-onset Pompe disease. Myozyme and Lumizyme are administered by intravenous infusion. Both products are recombinant forms of the same human enzyme. Fabrazyme Fabrazyme (agalsidase beta) is an enzyme replacement therapy used to treat Fabry disease, an inherited, progressive and potentially life threatening LSD. Fabry disease occurs in approximately 1 in 35,000 newborns worldwide, but the incidence and patient severity vary among regions. Fabrazyme has been marketed in the E.U. and in the U.S. Fabrazyme is
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