Amgen Wins EU Approval to Be First in New Cholesterol Drug Class

Amgen Inc. won approval in the European Union for its drug Repatha, the first regulatory clearance for a new class of powerful cholesterol-lowering drugs.

The European Commission granted Amgen authority to sell Repatha for patients with uncontrolled cholesterol who require additional intensive reduction of LDL, or bad, cholesterol, the company said in a statement Tuesday.

Repatha is part of a category of drugs known as PCSK9 inhibitors, designed to help patients who can’t get their LDL cholesterol under control with widely used statins such as Pfizer Inc.’s Lipitor, or who can’t tolerate the drugs. The U.S. Food and Drug Administration is expected to decide whether to approve Repatha by Aug. 27.

Another drug, called Praluent, from Sanofi and Regeneron Pharmaceuticals Inc., may be the first PCSK9 to market in the U.S. The FDA is expected to decide on Praluent by Friday, while the European Medicines Agency’s Committee for Medicinal Products for Human Use is supposed to review the drug this week.

“We are proud that our cholesterol-lowering medication, Repatha, is the first PCSK9 inhibitor to be approved by any regulatory agency in the world,” Sean Harper, executive vice president of research and development at Amgen, said in the statement.

High cholesterol is a major risk factor for cardiovascular disease, though Repatha’s ultimate effect on heart health isn’t known yet, Amgen said. More than 60 percent of high-risk patients in Europe are unable to lower their bad cholesterol with statins or other lipid-lowering therapies, according to the company statement.

The European Commission approved Repatha for adults with genetic forms of extremely high cholesterol known as hypercholesterolemia, as well as a version of the disease that doesn’t have a known genetic cause.