Panel supports Amgen drug
FDA advisors say the cholesterol-lowering medication should be allowed in some cases.
Federal health advisors said Wednesday that a highly anticipated cholesterol-lowering drug from Amgen Inc. should be approved for patients with dangerously high levels of the artery-clogging substance.
But as with their review of a similar drug a day earlier, the Food and Drug Administration experts noted that long-term results are needed to judge the drug’s real benefit.
The FDA advisory panel voted 11 to 4 that Amgen’s injectable drug Repatha appears safe and effective for some patients at high risk from cholesterol, particularly those with inherited conditions that cause cholesterol buildup. The FDA is not required to follow the group’s advice, though it often does.
The endorsement came despite pending study results on whether Repatha ultimately lowers rates of heart attack and death. Results from an Amgen study on that question aren’t expected until 2017.
Repatha is part of a new class of biotech drugs that lowers cholesterol more than older statin medications, which have been the standard treatment for more than 20 years. Thousand Oaks-based Amgen is racing rivals Sanofi and Regeneron, which received a positive vote Tuesday for their drug, Praluent.
Both Praluent and Repatha lower low-density lipoprotein, or LDL, cholesterol more powerfully and in a different way from statins. They block a substance called PCSK9, which interferes with the liver’s ability to remove cholesterol from the blood. Adding the new drugs to older statins has been shown to reduce LDL, or “bad,” cholesterol, from 40% to 60%. Statins alone generally lower levels of the wax-like substance about 30% to 50%.
The prospect of approving a pricey new class of drugs for one of the most common medical conditions in the U.S. is already drawing concerns from health insurers, employers and other payers who would absorb the costs.
More than 73 million U.S. adults have high LDL cholesterol, according to the Centers for Disease Control and Prevention.