On the back of a heart-helping win for the 11-year-old Repatha last fall, Amgen has continued to deepen the evidence on its PCSK9 inhibitor’s ability to cut cardiovascular risks in many patients.
But even as this triggers an “inflection” in Repatha’s own trajectory, “the urgency to treat patients and to get to a guideline recommended LDL-C level is quite remarkably slow,” Amgen’s chief medical officer, Paul Burton, M.D., Ph.D., said in an interview with Fierce ahead of the 2026 European Society of Cardiology Congress this past weekend.
The results from a series of real-world studies and analyses on the phase 3 Vesalius-CV trial shared by Amgen suggest that patients experiencing first CV events who survive are 63% more likely to suffer a second heart attack, stroke or revascularization events.
“These people are at real risk,” Burton explained, “not only of a primary event, but then going on and having more events after that.”
Headlining the readouts, meanwhile, was a subanalysis of Vesalius-CV tying Repatha to a 20% reduction in all-cause mortality (ACM) in more than 12,000 high-risk adults who hadn’t had a prior heart attack or stroke. Repatha was given on top of statins or other low-density lipoprotein cholesterol (LDL-C)-lowering medicines. The results were also published in the journal Circulation on Monday.
Amgen further touted Repatha’s ability to curb the risk of myocardial infarction by 36% in the analysis, with Burton noting that he found the apparent emergence of benefit within six months of treatment on the drug as “particularly striking.”
“So, this occurs early and continues to grow over time,” he said.
As for the mortality results, “again, I think here an important finding [is] that occurs within 18 months of the treatment,” Burton pointed out.
“So, starting this medicine, you get the MI benefit very early,” he argued. “You get a mortality benefit by a year-and-a-half. I think when you take all of that together, it says in the real world there needs to be more urgency—more focus on getting patients’ LDL-C lower.”
Vesalius-CV initially read out last fall, supporting Repatha’s ability to significantly curb the risk of major adverse cardiovascular events (MACE) over standard of care treatment alone in people who hadn’t had a heart attack or stroke before.
The trial enrolled 12,257 patients at a median age of 66 years who had qualifying atherosclerosis or high-risk diabetes, no prior heart attack or stroke, and who met certain LDL-C thresholds.
Repatha, also known as evolocumab, was first approved by the FDA in 2015 to help patients lower their LDL, or “bad,” cholesterol. The drug scored its initial heart attack and stroke prevention nod in the U.S. in 2017 and last year expanded its label to include an indication in adults at increased risk for MACE due to uncontrolled LDL-C.
The heart data Amgen has been generating has led to “a real sea change in the management of patients with high lipids and cardiovascular disease on primary prevention,” Burton said, “and so I think that has really led to this inflection in use of Repatha that we have seen.”
In this year’s second quarter, Repatha sales climbed 37% to reach $953 million as new-to-brand prescriptions for the drug went up 50% year over year for the period.
That renewed momentum has indeed been driven in large part “by cardiologists who are already using Repatha” and “using more of it for more patients,” Murdo Gordon, Amgen’s EVP of global markets and policy, told Fierce in August.
In primary care specifically, “we’re seeing an increase in depth of prescribing,” Gordon said, “particularly for diabetes patients, where your cardiovascular risk is very, very high compared to a patient who does not have Type 2 or Type 1 diabetes.”
Amgen also unveiled data at the American Diabetes Association’s 2026 Scientific Sessions this summer in 6,000 patients with high-risk diabetes and elevated LDL-C, in which Repatha plus statins or other cholesterol-lowering meds charted a 29% lower risk of coronary heart disease death, myocardial infarction or ischemic stroke over placebo.
Nevertheless, barriers for uptake to Repatha persist, Burton said.
Citing data from one of the real-world studies Amgen presented this past weekend, he noted that only some 42% of patients at high risk of a first cardiovascular event are taking a lipid-lowering therapy—primarily in the form of a solo statin—with just 24% currently meeting their LDL-C goal. Burton described those numbers as “shockingly low.”
“I think there’s long-standing misconceptions about the use of PCSK9s and Repatha,” he said, citing access as one example.
But with comprehensive coverage and payment assistant plans in place, that should not be cause for concern, the Amgen CMO argued.
In one potential silver lining for continued PCSK9 uptake, Burton noted that the American Academy of Family Physicians recently endorsed new guidelines on lipid management from the American Heart Association and the American College of Cardiology, which he framed as an “important” endorsement for practice.
As it stands, those guidelines encourage LDL-C levels of below 100 mg/dL for patients at borderline or intermediate risk, below 70 mg/dL for those at high risk and less than 55 mg/dL among patients at very high risk who’ve had a previous CV event.
To Burton’s mind, in light of the Vesalius-CV data, “just being on a statin is not going to get you there.”