Amgen Inc. announced Friday that a European Union committee has recommended approval of its drug Repatha to treat high cholesterol.
The Thousand Oaks biotech said the Committee for Medicinal Products for Human Use of the European Medicines Agency has “adopted a positive opinion” to allow marketing for patients who don’t respond or have intolerance to other cholesterol drugs.
Repatha, also called evolocumab, is a new type of cholesterol medicine called a PCSK9 inhibitor that helps the liver remove “bad” cholesterol from the bloodstream. Most current cholesterol drugs are statins, which inhibit production of cholesterol in the liver.
Lipitor, the best-selling statin from Pfizer Inc., had sales of $2 billion last year, but it regularly posted annual sales of more than $10 billion before its patent expired in 2011.
The committee’s recommendation now goes to the European Commission, which can approve the medicine for sale in the 28-country European Union.
Dr. Sean Harper, Amgen’s executive vice president of research and development, said the recommendation was a step toward helping patients who can’t lower their cholesterol with current options.
“Uncontrolled high cholesterol is a burden on the health system and we look forward to continuing to work with regulatory authorities to bring Repatha to patients across Europe,” he said in a statement.
In the United States, Amgen has submitted the drug to the Food and Drug Administration and is awaiting review.
Amgen shares closed Friday down 26 cents, or a fraction of a percent, to $163.58 on the Nasdaq.
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