WASHINGTON (AP) Amgen Inc. says European regulators have approved its first-of-a-kind cholesterol drug that lowers levels of the artery-clogging substance more than older drugs that have been prescribed for decades.
Advertisement
High cholesterol is a major risk factor for cardiovascular disease, though Repatha’s ultimate effect on heart health isn’t known yet, Amgen said. LDL is also called bad cholesterol.
Amgen Inc’s cholesterol treating prescription was in fact legal from the European Commission, presenting the zealously looked forward to treatment method a start with a challenge prescription in development by Regeneron Pharmaceuticals Inc and Sanofi SA. 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.
The European Commission granted Amgen authority to sell Repatha for patients with uncontrolled cholesterol who require additional intensive reduction of LDL, or bad, cholesterol, the company said in a statement Tuesday.
Advertisement
Amgen’s drug is designed for biweekly doses of 140 mg or a monthly dose of 420 mg on top of statins if patients can tolerate them. The U.S. Food and Drug Administration is expected to decide whether to approve Repatha by August 27. The FDA is not bound to follow panel recommendations but it usually does.
