European drug regulators have approved Amgen’s highly anticipated, first-of-a-class cholesterol-lowering drug Repatha, for patients with dangerously high cholesterol levels, including those with inherited conditions, and people who cannot tolerate statin side effects.
Repatha is an injectable drug from an experimental class of drugs known as PCSK9 inhibitors. Other PCSK9 drugs are currently in development or awaiting review by drug regulators. Drugs in this class have shown in clinical trials to be superior at dramatically lowering LDL – or bad – cholesterol. Like statins, the drugs are used to prevent heart attacks and strokes in patients with high cholesterol, a risk factor for heart disease and related cardiovascular problems.
The U.S. Food and Drug Administration (FDA) is scheduled to decide the fate of Repatha and another PCSK9 inhibitor, Praluent, made by Regeneron and Sanofi.
PCSK9 inhibitors may provide impressive efficacy data, but researchers have raised concerns over potential side effects, which one report described as new onset diabetes, pancreatitis, and kidney disorders. Statin side effects are already raising red flags, with the latest studies showing an increased risk of new onset type 2 diabetes in patients who use them.
Drug regulators have also questioned the cost of the new class of meds, which could ring as high as $10,000 annually according to some analysts. Statins, on the other hand, are readily available in less expensive generic versions.