In a significant advancement for cardiovascular disease management, Amgen’s Repatha (evolocumab) has received approval from the U.S. Food and Drug Administration (FDA) to prevent heart attacks, strokes, and coronary revascularizations in adults with heart disease. This marks the first approval of a PCSK9 inhibitor for these specific conditions, highlighting a major step forward in the treatment of heart disease.

FDA Approval for Repatha

Repatha, a human monoclonal antibody designed to inhibit the protein PCSK9, effectively reduces low-density lipoprotein cholesterol (LDL-C), a key contributor to heart disease. Previously approved by the FDA as an adjunct to diet and lipid-lowering therapies such as statins for primary hyperlipidemia, Repatha’s new indication offers hope to patients who are still at high risk of cardiovascular events despite receiving current best therapies.

Clinical Trial Success Demonstrates Efficacy

The efficacy of Repatha was demonstrated in the FOURIER phase 3 trial, which included 27,564 patients. The trial results were impressive, showing that Repatha reduced the risk of heart attack by 27%, stroke risk by 21%, and the risk of coronary revascularization by 22%. The objective of the placebo-controlled FOURIER trial was to determine whether Repatha combined with high- or moderate-intensity statin therapy could significantly reduce cardiovascular events compared to placebo plus statin therapy.

Amgen’s Commitment to Cardiovascular Health

Sean Harper, Executive Vice President of Amgen Research and Development, expressed his enthusiasm about the new approval: “Physicians now have a new FDA-approved treatment option to prevent cardiovascular events by dramatically lowering LDL cholesterol with Repatha, especially for patients already on maximally-tolerated statin therapy who need further LDL cholesterol lowering.”

Anthony Hooper, Executive Vice President of Amgen Global Commercial Operations, underscored the societal impact of cardiovascular disease and the importance of this approval: “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. 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.”

Future Implications and Access to Repatha

Amgen is committed to working with payers to ensure that patients who need Repatha the most have access to this innovative medicine. This approval is expected to change the landscape of cardiovascular disease treatment by providing patients with a powerful tool to prevent life-threatening cardiovascular events.

This FDA approval of Repatha as a preventive treatment for cardiovascular events represents a pivotal advancement in cardiac care, offering a new, effective option for reducing the burden of heart disease on patients and the healthcare system.

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