On the heels of an FDA label expansion in August, Amgen reported that its late-stage Vesalius-CV study showed Repatha (evolocumab) significantly reduced the risk of major adverse cardiovascular events (MACE) compared with standard-of-care treatment alone in people without a prior heart attack or stroke.
Amgen stated that the trial followed more than 12,000 high-risk patients over a median period of approximately four and a half years. About 85% of participants were also receiving maintenance doses of a high-intensity or moderate therapy to manage low-density lipoprotein cholesterol (LDL-C), commonly called “bad” cholesterol, the company noted. That high proportion receiving background lipid-lowering therapy gives a view into the broader primary prevention population the company could address, analysts said.
Analysts at Citi described the background-therapy population as particularly noteworthy for the light it sheds on a larger primary prevention market, while also indicating the Vesalius-CV results are more likely to supplement Repatha’s existing data package than to create a dramatic sales inflection, their note said.
Amgen said the Vesalius-CV study met both of its primary endpoints. The two key endpoints assessed time to the first occurrence of a composite including coronary heart disease death, heart attack, or ischemic stroke, and time to the first occurrence of a composite that added any ischemia-driven arterial revascularization. Amgen provided a topline readout in its announcement and plans to present full Vesalius-CV results at a meeting of the American Heart Association in November.
“These results mark an important milestone in the fight against cardiovascular disease, the leading cause of death worldwide,” said Jay Bradner, M.D., Amgen’s executive vice president of R&D. He added that the new data indicate Repatha may be able to reach many more patients earlier, before a life-altering cardiovascular event occurs.
Repatha was first approved in 2015 to treat certain patients with high cholesterol and later earned its first cardiovascular indication in late 2017 for preventing heart attacks, strokes, and coronary revascularizations in adults with established cardiovascular disease.
In August, the FDA broadened Repatha’s label by removing the prior diagnosis requirement for cardiovascular disease and updating the indication to include adults at increased risk for MACE due to uncontrolled LDL-C. This change moves the medicine into the primary prevention setting for at-risk adults without established cardiovascular disease.
Amgen emphasized that a heart attack or stroke occurs in the U.S. every 40 seconds and that 75% of those events represent first-time cardiovascular events. The company also noted that, while high LDL-C is among the most modifiable risk factors for heart attack or stroke, many patients with elevated cardiovascular risk factors continue to struggle to reach LDL-C goals.
