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Amgen recently announced that the U.S. Food and Drug Administration (FDA) has approved the company's repatha ® supplemental biologics licensing application (sBLA) as the first PCSK9 inhibitor to prevent heart disease and cardiovascular disease, stroke and coronary artery blood transport to rebuild adults. Can significantly reduce the risk of major adverse cardiovascular events by up to 20%.
in the United States, one person has a heart attack or stroke every 40 seconds, and nearly a third end up with a heart attack or stroke, which costs more than $600 billion a year.
repatha's effects were validated in an international Phase 3 clinical trial called FOURIER, in which 27,564 patients participated, and found that adding repatha to optimized statin therapy significantly reduced the risk of major adverse cardiovascular events by up to 20 percent
. Individually, the treatment reduced the risk of heart disease by 27 percent, stroke by 21 percent, and the risk of coronary blood transfusion reconstruction by 22 percent.
repatha is a human-derived monoclonal antibody that binds and inhibits the PCSK9 protein. In the human body, pcSK9 proteins bind to low-density lipoprotein (LDL) receptors, causing them to degrade. Once PCSK9 is suppressed, the LDL receptor in the blood can return to the surface of the liver cell, removing the LDL from the blood and lowering the body's "bad cholesterol" levels."We are very pleased that the FDA has prioritized our data so that patients can benefit from Repatha and reduce life-changing heart and stroke events," said Dr. Sean E. Harper, executive vice president of research and development at Amin.
Doctors now have a new FDA-approved treatment to prevent cardiovascular events by significantly lowering LDL cholesterol levels. This can help patients who have already had the greatest tolerance for statin therapy to further lower LDL cholesterol levels. the
FDA also approves repatha as an aid to diet, individually or in combination with other lipid-lowering treatments, such as statins, to reduce LDL-C 1 treatment in adults with primary hyperlipidemia. (Compiled)Literature Source:
(1)
Amgen
Website:
FDA Approves Amgen's Repatha ® (evolocumab) To Prevent Heart Heart Attack And Stroke
.