Sanofi, Regeneron submit new cholesterol drug to EMA for review

[January 12, 2015]  PARIS (Reuters) - The European Medicines Agency has agreed to review an application by Sanofi and Regeneron for their cholesterol-lowering drug alirocumab, the pharmaceutical groups said in a statement on Monday.

The drug, for which the companies have proposed to market under the name Praluent, has also been under review by the U.S. Food and Drug Administration since the fourth quarter of 2014.

Alirocumab belongs to a new class of potent drugs that block a naturally occurring protein called PCSK9 that prevents the liver from removing LDL, or "bad", cholesterol from the blood. They are expected to be used mainly by people who cannot take statins, the standard cholesterol-lowering treatment, because of side effects.

Sanofi and Regeneron are racing Pfizer and Amgen to bring PCSK9 inhibitors to the market, which is expected to be worth billions if the drugs are shown to significantly reduce heart attacks and deaths as statins have.

The marketing application for alirocumab in Europe included data from more than 5,000 patients and ten clinical trials, the companies said.

(Reporting by Leila Abboud; Editing by Clarence Fernandez)

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