Biotech giant Amgen (NASDAQ:AMGN) won U.S. approval for its pricey cholesterol-lowering drug Repatha for certain patients, making it the second in a new class of treatments to come to market.
The Amgen therapy, Repatha, belongs to a powerful new drug class that promises help for patients who have struggled to control their cholesterol using older statin medicines. In July, the Food and Drug Administration approved the first drug of this new class, Praluent, from Sanofi SA (NYSE:SNY) and Regeneron Pharmaceuticals (NASDAQ:REGN).
Both drugs will cost more than $14,000 a year.
Doctors and patients have been looking forward to these new cholesterol-lowering agents, which are injections either monthly or every two weeks.
Some 11 million Americans face increased risks of heart disease because they cannot control their cholesterol with existing drugs and methods.
The FDA approved the drug Thursday for two groups of patients who face the highest risk of heart disease:
— patients with extremely high levels of LDL, or bad cholesterol, due to inherited conditions
— patients with persistently high LDL levels and a history of heart attack, stroke and other cardiovascular problems
The biologically-engineered drugs are considered the first major advance in managing cholesterol since the introduction of statin drugs more than 20 years ago, and analysts expect them to generate billions in sales.
Shares of Amgen fluctuated in Friday’s trading and were last trading at $156.38, up 0.4%, at 10:07 a.m. in New York. The stock has gained 13% over the past year.