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FDA approves evolocumab for strokes, heart attacks

12/ 11



DATE: Dec 11, 2017


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FDA approves evolocumab for strokes, heart attacks

On Dec. 1, the U.S. Food and Drug Administration approved the PCSK9 inhibitor evolocumab (Repatha) to prevent heart attacks and strokes. It is the first PCSK9 approved for these conditions in adults with cardiovascular disease, notes Amgen in a release.

Many patients, who had already been receiving the best therapies available, remained at high risk for heart attack, according to Sean Harper, Amgen’s executive vice president of research and development.

“Physicians now have a new FDA-approved treatment option to prevent cardiovascular events by dramatically lowering LDL cholesterol with Repatha,” he said in the release.

The release cites a study, which included 27,564 patients and found that evolocumab can reduce heart attack risk by 27 percent and stroke risk by 21 percent.

Heart attacks and strokes, which happen every 40 seconds in the U.S., cost the nation more than $600 billion annually, according to Anthony Cooper, Amgen’s executive vice president of global commercial operations.

“With this approval, it’s now more important than ever that appropriate patients obtain access to Repatha in order to avoid preventable heart attacks and strokes,” he said in the release.

“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,” explains the San Fernando Valley Business Journal. “The drug was previously approved to treat high cholesterol in patients who were taking the maximally tolerable dose of statins, another type of drug.”


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