FDA approves extension of Regeneron / Sanofi cholesterol drug label

(Reuters) – The US Food and Drug Administration on Friday approved Praluent, a cholesterol drug from Regeneron Pharmaceuticals Inc., as a treatment to reduce the risk of heart attacks, strokes, and other events major cardiovascular diseases.

The FDA's decision will prescribe the drug, developed in conjunction with Sanofi SA, to reduce the overall risk of major adverse cardiovascular events (MACE).

MACE includes heart attacks, ischemic strokes, coronary artery disease and unstable chest pain requiring hospitalization.

Praluent belongs to a clbad of injectable biotechnology drugs, called PCSK9 inhibitors, which significantly lower LDL cholesterol and reduce the risk of heart attack and death.

The FDA has also approved Praluent as a diet additive, alone or in combination with other lipid-lowering therapies, for the treatment of adults with primary hyperlipidemia to reduce LDL-C levels.

In 2015, Praluent was approved in the United States for use as a treatment adjunct to statin therapy in adults with heterozygous familial hypercholesterolemia, a disease that causes a sharp increase in the rate of cholesterol in the blood. (Bit.ly/1KM8WQf)

In February, Sanofi and Regeneron reduced Praluent's list price by 60% to bring it closer to the Amgen Inc Repatha price, another treatment to reduce the risk of heart attack, as drug companies try to boost sales of the drug.

Praluent's new list price will be $ 5,850 a year, compared to more than $ 14,000 a year when it is first approved in 2015.

Praluent and Repatha sales were severely limited by barriers put in place by insurers seeking to limit their spending on expensive drugs.

Praluent has been approved in more than 60 countries worldwide, including the United States, Japan, Canada, Switzerland, Mexico and Brazil, as well as the European Union.