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FDA accepts Genzyme-Isis cholesterol drug for review

Agency will analyse Kynamro’s ability to reduce levels of cholesterol in patients with rare genetic disorder

The US Food and Drug Administration (FDA) has accepted a new drug application (NDA) for Kynamro, a cholesterol-lowering drug developed by Isis and Sanofi's Genzyme business.

Kynamro (mipomersen sodium) is a novel treatment for patients with homozygous familial hypercholesterolaemia (HoFH) – a rare genetic condition that results causes the cells that process LDL cholesterol in the body to malfunction, leading to excess cholesterol.

It works by blocking the production of apolipoprotein B, a protein that is necessary in the formation of atherogenic lipoproteins that carry cholesterol through the bloodstream.

Isis and Genzyme submitted the application for Kynamro in March, 2012, and the FDA's decision to review the drug means that the drug's initial discoverer Isis is entitled to a $25m milestone payment from Genzyme.

The FDA will now analyse data from what Genzyme says is the largest clinical trial conducted in people with HoFH, and which demonstrated significant reductions in levels of LDL cholesterol among patients receiving Kynamor who were already receiving a regimen of lipid lowering therapies.

"The NDA filing with the FDA represents a significant achievement in the development of Kynamro and our efforts to get this important new drug to the market for patients who are at high-risk of a cardiovascular event,” said Dr David Meeker, president and CEO, Genzyme.

Isis and Genzyme also have plans to file the drug in other indications, expanding Kynamro's potential beyond homozygous familial hypercholesterolaemia, which is thought to affect about one in 1m people.

The partners have ongoing trials of Kynamro in severe heterozygous familial hypercholesterolemia (HeFH), another genetic condition that causes levels of cholesterol to rise and is thought to affect one in 500 people.

Other drugs currently in development for this condition include another Sanofi-owned treatment, SAR236553/REGN727, which the French pharma firm is developing with Regeneron.

The investigational product recently demonstrated positive performance in its ability to reduce LDL cholesterol in a phase II trial.

31st May 2012

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