Genzyme, a Sanofi company (SNY: Quote, SNYNF.PK), and Isis Pharmaceuticals Inc. (ISIS), announced that the U.S. Food and Drug Administration, or FDA, has accepted for filing the New Drug Application, or NDA, for KYNAMRO (mipomersen sodium) for the treatment of patients with homozygous familial hypercholesterolemia, or HoFH. The NDA filing with the FDA triggers a $25 million milestone payment to Isis from Genzyme.
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 for patients receiving KYNAMRO who are already receiving a regimen of maximally tolerated lipid lowering therapies including statins. Three patients treated with KYNAMRO withdrew due to adverse events.
Consistent with other studies evaluating KYNAMRO, commonly observed adverse events included mild to moderate injection site reactions and flu-like symptoms, as well as elevations in liver transaminases.
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by RTT Staff Writer
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