Genzyme and Isis Pharmaceuticals announced that the FDA has accepted for filing the New Drug Application (NDA) for Kynamro (mipomersen sodium) for the treatment of patients with homozygous familial hypercholesterolemia (HoFH).
The FDA submission for Kynamro is supported by the largest clinical trial conducted to date in the HoFH patient population. In the randomized, double-blind, placebo controlled, multi-center trial, significant reductions were observed in all atherogenic lipoproteins evaluated (including LDL-C, Apo B and Lp(a)) for patients receiving Kynamro who are already receiving a regimen of maximally tolerated lipid lowering therapies including statins.
Kynamro is a first-in-class apo-B synthesis inhibitor that reduces LDL-C by preventing the formation of atherogenic lipids. It acts by decreasing the production of apo-B, which provides the structural core for all atherogenic lipids, including LDL-C, which carry cholesterol through the bloodstream.
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