FDA Approves Label Expansion for Amgen’s Repatha

The Food and Drug Administration has approved Amgen Inc.’s drug Repatha as a prevention for heart attacks in patients with cardiovascular disease, potentially enlarging the customer base for the drug. The FDA’s decision was based on a recent study by the Thousand Oaks biopharma. Data from the study is now approved for inclusion in Repatha’s prescribing information. “We are pleased that the FDA made the inclusion of our outcomes data a priority so that patients can benefit from Repatha’s ability to reduce life-changing events of heart attacks and strokes,” Dr. Sean Harper, executive vice president of research and development at Amgen, said in a statement. “Physicians now have a new FDA-approved treatment option to prevent cardiovascular events by dramatically lowering LDL.” The injectable Repatha reduces levels of low-density lipoprotein (LDL) cholesterol – or “bad” cholesterol – by blocking an enzyme called PCSK9 that prevents the clearance of LDL cholesterol from the bloodstream. The drug was previously approved to treat high cholesterol in patients who were taking the maximally tolerable dose of statins, another type of drug. While other large pharmaceutical companies have also developed PCSK9 inhibitors, Repatha is the first to be greenlit by the FDA for the prevention of major cardiovascular events in high-risk patients. Amgen announced the label change on Friday after trading hours. The company’s stock (AMGN) rose $1.54, or about 1 percent, during the day to close at $177.20 on the Nasdaq.