July 24, 2015 / 6:27 PM / 4 years ago

FDA approves Sanofi/Regeneron cholesterol drug with limits

WASHINGTON (Reuters) - The U.S. Food and Drug Administration approved a potent new cholesterol-lowering drug from Sanofi SA and Regeneron Pharmaceuticals Inc on Friday but limited its approved use to patients with a hereditary form of the condition and those with cardiovascular disease.

The FDA ruling came just hours after European regulators recommended approval for broader use of the drug, called Praluent, in all patients with high cholesterol who are not able to bring it down despite taking maximal doses of statin. The Europeans also recommended it for patients who cannot tolerate statins.

The companies expect the drug to receive formal approval by the European Commision in late September. The Commission recently approved a rival drug made by Amgen Inc, Repatha.

In restricting its approval to a narrower patient population the FDA followed the advice of members of its advisory panel, who in June recommended its use be limited to those with a genetic predisposition to high cholesterol and at high cardiovascular risk who are on maximum doses of statins.

Praluent and Repatha are the first in a new class of LDL-lowering drugs that inhibit a protein known as PCSK9. The FDA is expected to rule on Repatha by Aug. 27.

Each drug is expected to generate annual sales of more than $2 billion by 2020, according to Thomson Reuters data.

Praluent is given every other week by injection in doses of 75 mg or 150 mg. Repatha is designed to be given as a 140 mg injection every other week or a monthly injection of 420 mg.

On July 21, European regulators approved Repatha with a broad label covering patients with the inherited form of high cholesterol known as familial hypercholesterolemia (FH) and those with non-familial hypercholesterolemia.

Reporting by Toni Clarke; Editing by Bernard Orr

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