Amgen Receives Positive CHMP Opinion Recognizing That Repatha® (evolocumab) Prevents Heart Attacks And Strokes

THOUSAND OAKS, Calif., today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion to include a new indication in the Repatha® (evolocumab) label for adults with established atherosclerotic cardiovascular disease (myocardial infarction, stroke or peripheral arterial disease) to reduce cardiovascular risk by lowering LDL-C levels. The recommended label recognizes the positive findings from the Repatha cardiovascular outcomes study (FOURIER) and includes data on the additional reduction and prevention of heart attacks, strokes and coronary revascularizations on top of maximally tolerated statin therapy.

The Repatha cardiovascular outcomes study showed reductions in 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 in patients treated with Repatha and statin therapy compared to patients treated with placebo and statin therapy over a mean duration of 26 months.

"We welcome the CHMP's positive opinion to incorporate a new indication for adults with cardiovascular disease into the European label, recognizing the impact of Repatha to prevent life-changing events such as heart attacks and strokes," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "With the FOURIER outcomes data now included in the U.S. label and an anticipated label update in Europe in the coming months, we will continue to work with payers globally to ensure access to medication for higher-risk patients. Furthermore, we value and support the efforts by many stakeholders, including clinicians, advocates and payers, as we all work to reduce barriers to access and increase affordability for patients who need PCSK9 treatment."

The CHMP's positive opinion will now be reviewed by the European Commission (EC), which has the authority to approve medicines for the European Union (EU). If approved, the centralized European marketing authorization for Repatha will be updated to include the new indication. Norway, Iceland and Liechtenstein, as members of the European Economic Area (EEA), will take corresponding decisions on the basis of the EC's decision.

On Dec. 1, 2017, the U.S. Food and Drug Administration (FDA) approved a new indication for Repatha as the first PCSK9 inhibitor to prevent heart attacks, strokes and coronary revascularizations in adults with established cardiovascular disease following a priority review of Amgen's supplemental Biologics License Application.