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Title: Sanofi, Regeneron Cholesterol Drug Also Effective in Monthly Doses
Source: [None]
URL Source: [None]
Published: Jan 13, 2015
Author: By Reuters Staff
Post Date: 2015-01-13 04:53:47 by Tatarewicz
Keywords: None
Views: 9

(Reuters) - An experimental drug from Sanofi SA and Regeneron Pharmaceuticals was found to be effective in lowering LDL cholesterol even when administered once every four weeks, instead of every two weeks.

The drug, alirocumab, belongs to an emerging class of injectable drugs that block a naturally occurring protein called PCSK9, which inhibits the liver from expelling LDL cholesterol.

These PCSK9 inhibitors are aimed at patients whose cholesterol levels do not fall enough despite the use of statins such as Pfizer Inc's Lipitor, and those who are unable to tolerate them.

Alirocumab was tested in 803 high cholesterol patients with a moderate-to-high heart risk. It compared a 300 mg dose of the drug given every four weeks against a placebo, with over two-thirds of the patients also on statins.

A second study evaluated alirocumab in 233 high cholesterol patients with a high heart risk and/or a history of being unable to tolerate two or more statins. The trial compared a 150 mg dose of the drug given every four weeks against a placebo.

Early data from another trial suggested alirocumab could halve heart risk. A study also proved that the number of high-risk statin-intolerant patients able to get their LDL cholesterol down using alirocumab was 10 times more than those on Merck & Co's Zetia.

Sanofi SA and Regeneron are in a fierce race with Pfizer and Amgen Inc to bring their PCSK9 inhibitor to the market, which is expected to be worth billions if these biotech drugs are also able to significantly reduce heart attacks and deaths as statins have.

Amgen has a head start, having submitted a marketing application for its drug, evolocumab, with the U.S. Food and Drug Administration in August.

Hoping to close the gap, Sanofi and Regeneron paid BioMarin Pharmaceutical $67.5 million for a voucher that could speed up alirocumab's review process.

www.medscape.com/viewarticle/837841

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