Repatha (evolocumab), Amgen's cholesterol fighting drug, was green-lighted by the European Commission giving the treatment a head start over other similar drugs developed by other drug companies such as Sanofi and Regeneron Pharmaceuticals.
The drug is for the treatment of individuals with uncontrolled cholesterol who require additional reduction in low-density lipoprotein (LDL), otherwise known as bad cholesterol.
The approval is the first for a new class of drugs known as PCSK9 inhibitors. Amgen did not yet reveal when the drug could become available in the market or its pricing strategy but such biologic drugs are anticipated to be more expensive compared with statins such as Pfizer's Lipitor.
Amgen said on Tuesday that the European Commission's (EC) approval will cover patients who are genetically predisposed to having high cholesterol, those who are intolerant to statins and those who cannot experience enough benefit from using statins.
"We are proud that our cholesterol-lowering medication, Repatha, is the first PCSK9 inhibitor to be approved by any regulatory agency in the world," said Amgen Research and Development executive vice president Sean Harper. "We are excited to make this new cholesterol-lowering medication available for patients in Europe."
Harper said that high LDL cholesterol is a global health burden with many patients unable to control their LDL cholesterol with statin's maximum tolerated dose. Some individuals cannot also take statins because of contraindication or intolerance to the drug.
John J.P. Kastelein, from University of Amsterdam's Academic Medical Center, said that many of the patients who take cholesterol lowering treatments including those who have familial hypercholesterolemia, a genetic disorder marked by very high levels of LDL in the blood and early onset of cardiovascular disease, still have difficulty managing their bad cholesterol level.
Kastelein said that the go signal for the marketing of Amgen's drug in EU provides physicians an option for treating patients with uncontrolled cholesterol and whose LDL cholesterol level needs to be further reduced.
The recommended dose of the drug for adults is ether 140 mg every two weeks or 420 mg once a month with both doses considered as clinically equal.
A panel advising the U.S. Food and Drug Administration (FDA) has recommended for the approval of the drug last month and the federal health regulator is anticipated to make its decisions this summer. The FDA is not bound to follow panel recommendations but it usually does.
Photo: Steven Depolo | Flickr
