FDA approves Amgen's Repatha for prevention of heart attacks and strokes

The FDA on Friday cleared Amgen's Repatha (evolocumab) for the prevention of heart attacks, strokes and coronary revascularisations in adults with established cardiovascular disease. The drugmaker noted that the drug is the first PCSK9 inhibitor to be authorised for preventing such cardiovascular events. Amgen R&D chief Sean Harper said "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."

According to Amgen, the approval  was backed by safety and efficacy data from the FOURIER trial. In the 27 564-patient study, the results of which were unveiled in March, the addition of Repatha to optimised statin therapy was associated with a 20-percent reduction in the risk of major adverse cardiovascular events, as well as a 15-percent lower risk of the composite endpoint of hospitalisation for unstable angina, coronary revascularisation, heart attack, stroke or cardiovascular death. Specifically, data showed that Repatha reduced the risk of heart attack by 27 percent, the risk of stroke by 21 percent, and the risk of coronary revascularisation by 22 percent.

Amgen's head of global commercial operations Tony Hooper remarked "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", adding "we will continue to work with payers to help ensure the patients who need Repatha the most are able to get this innovative medicine".

Repatha was initially approved by the FDA in 2015 for use in combination with maximally tolerated statins for the treatment of adults with heterozygous familial hypercholesterolaemia, homozygous familial hypercholesterolaemia or clinical atherosclerotic cardiovascular disease who require additional lowering of LDL cholesterol. 

In October, a US appeals court overturned a lower court decision blocking Sanofi and Regeneron Pharmaceuticals from marketing the PCSK9 inhibitor Praluent (alirocumab). The ban was initially instituted when a federal jury upheld patents protecting Repatha and determined that those patents were infringed by Praluent. For related analysis, read ViewPoints: Patients, payers unlikely to rue appellate ruling in PCSK9 legal battle.

 

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