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Amgen's Repatha Wins FDA Approval

Monday, December 11, 2017   (0 Comments)
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Amgen recently attained approval from the Food and Drug Administration (FDA) for Repatha following a priority review of the company’s supplemental biologics license application.

"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, Amgen’s executive vice president of research and development, said in a company press release.

Repatha is the first PCSK9 inhibitor to be approved for the prevention of heart attacks, strokes and related events in adults with cardiovascular disease, according to the release. Studies demonstrated that the treatment reduces the risk of heart attack by 27 percent, the risk of stroke by 21 percent and the risk of coronary revascularization procedures by 22 percent.

Anthony Hooper, Amgen’s executive vice president of global commercial operations, said that heart attacks and strokes create enormous industry costs.

"In the U.S., every 40 seconds someone has a heart attack or stroke, and nearly one in three of these patients will have another event, leading to a societal cost that exceeds $600 billion annually,” Hooper stated. “With this approval, it's now more important than ever that appropriate patients obtain access to Repatha. … We will continue to work with payers to help ensure the patients who need Repatha the most are able to get this innovative medicine."


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