Genzyme,
a Sanofi company SNY, and Isis Pharmaceuticals
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.
"We are very encouraged by the support for KYNAMRO at today's Advisory
Committee meeting, which marks a significant and positive step in our
See full press release
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