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Regeneron-Sanofi's Praluent wins EU approval for reducing risks of heart disease

Regeneron Pharmaceuticals Inc. and Sanofi's cholesterol drug Praluent received the European Commission's approval to reduce the risk of heart attacks and strokes in certain patients.

The expanded approval allows Praluent to be used to reduce cardiovascular risk in patients with atherosclerotic cardiovascular disease, or ASCVD, by lowering low-density lipoprotein cholesterol levels — also known as bad cholesterol — one of the key factors responsible for cardiovascular disease.

ASCVD is a condition where the inside of an artery narrows due to the buildup of plaque and restricts blood flow to the heart. It can lead to a number of serious conditions such as stroke, peripheral artery disease and acute coronary syndrome, which includes heart attack and unstable angina.

Praluent is in a class of cholesterol drugs known as PCSK9 therapies.

The European approval is based on results from a phase 3 study, named Odyssey Outcomes, which showed that Praluent reduced the risk of major cardiovascular events, including heart attack, stroke and unstable angina, and was associated with reduced risk of death.

In January, the U.S. Supreme Court refused to take up a case brought by Amgen Inc. attempting to change a ruling from the U.S. Court of Appeals for the Federal Circuit that overturned a ban on Praluent sales, which is a rival to Amgen's Repatha.

However, a Delaware jury decided to uphold the validity of two Repatha patents — related to PCSK9 therapies — in February.

Amgen said the European Patent Office and the Japanese Patent Office also rejected challenges to the validity of its PCSK9 antibody patents brought by Sanofi, Regeneron and other potential competitors. The company said it plans to enforce these patents in national courts in Europe and Japan against Sanofi and Regeneron.

Sanofi and Regeneron have admitted to infringing Amgen's patent in making Praluent, but argued that these patents were invalid. They lowered the U.S. list price of Praluent by 60% in February.

Global net product sales of Praluent in the fourth quarter of 2018 were $93 million, including $60 million in the U.S., Regeneron's Senior Vice President and Head of Commercial Marion McCourt said on the company's earnings call.