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The United States Food and Drug Administration (FDA) and the European Commission have approved Repatha, a new inhibitor developed by Catalan based pharmaceutical companyAmgen for patients who are unable to get their “bad” cholesterol levels (LDL) under control.

Repatha is the second in a new class of drugs that block the protein PCSK (proprotein convertase subtilisin kexin) type 9. This protein reduces the liver’s capacity to eliminate low-density lipoprotein cholesterol (LDL-C) from the blood and is found in patients with familial hypercholesterolemia and heart disease.

The regulatory bodies will allow Amgen to give injections of the drug to patients with familial hypercholesterolemia or heart disease who aren’t seeing results with current treatments. The treatment will be combined with diet and other drugs to lower cholesterol levels.

Repatha has been proven effective in a study in which nearly 60% of patients were able to lower their cholesterol levels. Now the company is waiting for approval to market the product in Japan, which it applied for early this year. The drug is being developed in Japan through a joint venture of Amgen and Astellas Pharma Inc., Amgen Astellas BioPharma K.K.


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