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Amgen has announced breakthrough results from a major heart drug study showing that its cholesterol-lowering medication Repatha can dramatically reduce the risk of heart attacks and major heart-related problems in patients at risk for cardiovascular disease.

The Phase III VESALIUS-CV trial, presented at the American Heart Association's annual meeting in New Orleans, tested more than 12,000 patients with high-risk conditions such as atherosclerotic cardiovascular disease (ASCVD) or diabetes — but no prior history of heart attack or stroke.

Participants received either Repatha or a placebo alongside standard cholesterol-lowering treatments and were monitored for about four and a half years.

According to Amgen, Repatha met all of its main goals.

The drug reduced major cardiovascular events such as death, heart attack, or stroke by 25% and cut the risk of a first heart attack by 36% compared to standard treatment alone, CNBC reported.

It also lowered "bad" LDL cholesterol to around 45 mg/dL on average, showing no new safety issues during the trial.

"This trial answered questions that have been on the mind of investigators, physicians, and patients for some time," said Amgen CEO Bob Bradway in an interview with CNBC.

"When it comes to LDL cholesterol, lower is better — and the sooner you get to those lower levels, the better, especially for people at higher risk."

Repatha Cuts Heart Attack Risk in Major Trial

Repatha, a PCSK9 inhibitor approved by the FDA in 2015, works by helping the liver clear LDL cholesterol from the bloodstream.

With the new results, Amgen says Repatha is now the first PCSK9 inhibitor proven to prevent cardiovascular events in high-risk adults without prior heart attack or stroke, marking a major step in preventive heart care.

According to BioSpace, Dr. Paul Burton, Amgen's chief medical officer, called the findings "remarkable," saying they represent one of the clearest sets of cardiovascular data in decades.

Analysts at BMO Capital Markets agreed, suggesting the results could reshape treatment guidelines by encouraging earlier use of PCSK9 therapies in patients who fail to reach healthy LDL levels with statins alone.

Heart disease remains the leading cause of death in the United States, affecting millions of adults every year.

Bradway emphasized that nearly all heart attacks stem from modifiable risks like high LDL cholesterol. "This study shows we can make a real difference before tragedy strikes," he said.

Amgen now plans to update Repatha's labeling to reflect the new trial data and pursue regulatory approval for its expanded use.