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4 Feb 2013

FDA approval for cholesterol-lowering injections

A new injectible treatment for cholesterol has been approved by the FDA.

Genzyme and Isis Pharmaceuticals have received US Food and Drug Administration approval for a new drug application for Kynamrotm injections.

The mipomsersen sodium treatment, administered 200mg weekly in a subcutaneous fashion, has been approved as an additional treatment alongside lipid-lower medications to reduce low density lipoprotein-cholesterol (LDL-C), apoliprotein B and total cholesterol in patients with homozygous familial hypercholesterolemia (HoFH).

The rare condition involves the body being unable to properly process and remove LDL cholesterol from the blood, meaning that levels of so-called 'bad' cholesterol can rise significantly and result in cardiac arrest or mortality before the age of 30.

As a result of the approval, Genzyme will pay Isis $25 million in order to launch Kynamro commercially.
Dr Stanley T Crooke, chairman and chief executive of Isis, said: "Kynamro is the first systemic antisense drug to reach the market and is the culmination of two decades of work to create a new more efficient drug technology platform.

"We look forward to continuing to work with Genzyme toward a successful commercial launch of Kynamro and global expansion into other markets."

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