October 18, 2012

FDA Advisory Committee Recommends KYNAMRO™ for Homozygous Familial Hypercholesterolemia

- KYNAMRO™ may provide a novel, new treatment for patients in the U.S. who are at severe cardiovascular risk -

 

FDA Advisory Committee Recommends KYNAMRO™ for Homozygous Familial Hypercholesterolemia
- KYNAMRO™ may provide a novel, new treatment for patients in the U.S. who are at severe cardiovascular risk -

Paris, France and Carlsbad, California – October 18, 2012 – Sanofi (EURONEXT: SAN and NYSE: SNY), its subsidiary Genzyme, and Isis Pharmaceuticals Inc. (NASDAQ: ISIS), announced today that the Endocrinologic and Metabolic Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) voted 9 to 6 that Genzyme had provided sufficient efficacy and safety data to support the marketing of KYNAMRO™ (mipomersen sodium) for the treatment of patients with Homozygous Familial Hypercholesterolemia (HoFH). Many people with HoFH have aggressive cardiovascular disease beginning in childhood, and even with today’s therapies remain at significant risk of cardiovascular events.