FDA Advisory Committee recommends Kynamro for treatment of Homozygous Familial Hypercholesterolemia - 20-Oct-2012

Genzyme, a Sanofi company and Isis Pharmaceuticals have announced that the Endocrinologic and Metabolic Drugs Advisory Committee of the 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. the FDA has set a target action date under the Prescription Drug User Fee Act (PDUFA) of January 29, 2013. An application for marketing approval of Kynamaro is also pending in the European Union.