Amgen’s Repatha cuts cardiovascular mortality risk by 20%, analysis finds: “Urgency of treatment is growing”

An analysis found that Amgen’s cholesterol treatment Repatha reduced the risk of all-cause mortality by 20% in people at high risk for cardiovascular disease.

According to Fierce Pharma, a U.S. pharmaceutical industry publication, on the 2nd local time, Amgen said a subanalysis of the phase 3 VESALIUS-CV trial, which enrolled more than 12,000 high-risk adults with no history of myocardial infarction or stroke, found that Repatha reduced all-cause mortality (ACM) by 20%.

Repatha was administered in addition to low-density lipoprotein cholesterol (LDL-C)-lowering therapies such as statins. The results were also published in the medical journal Circulation on the 1st.

In the same analysis, Repatha reduced the risk of myocardial infarction by 36%. Paul Burton, Amgen’s chief medical officer (CMO), said the fact that the effect emerged within 6 months of treatment was “particularly striking.”

“Once patients start this drug, the myocardial infarction benefit appears very early, and the mortality benefit appears by a year and a half,” Burton said. “This means there is a greater need for urgency in lowering patients’ LDL-C further in real-world practice.”

According to real-world clinical research and analysis results released by Amgen, patients who survived a first cardiovascular event were 63% more likely to experience a second myocardial infarction, stroke or revascularization procedure.

Initial results from VESALIUS-CV were released last fall and showed that, among patients with no history of myocardial infarction or stroke, Repatha significantly reduced the risk of major adverse cardiovascular events (MACE) compared with standard treatment alone.

Repatha (generic name, evolocumab) is a PCSK9 inhibitor approved by the U.S. Food and Drug Administration (FDA) in 2015. Second-quarter sales this year rose 37% to $953 million (approximately 1.3151 trillion won), while new prescriptions increased 50% from the same period a year earlier.

Burton, however, pointed out that access to treatment remains low among high-risk patients. Only about 42% of people at high risk after a first cardiovascular event were taking lipid-lowering therapy, and just 24% had reached the LDL-C target.

He described the figure as “shockingly low” and said there are “long-standing misconceptions about the use of PCSK9 inhibitors and Repatha.”

Meanwhile, the American Academy of Family Physicians recently endorsed new lipid management guidelines from the American Heart Association and the American College of Cardiology. The guidelines recommend lowering LDL-C to less than 70 mg/dL in high-risk patients and to less than 55 mg/dL in very-high-risk patients with a history of cardiovascular events.