Nov 8 (Reuters) - Adding Amgen's cholesterol

drug Repatha to standard therapy reduced major cardiovascular

events by 25% for at-risk patients who have never had a heart

attack or stroke, according to results from a large study

presented on Saturday.

In the study of more than 12,000 patients, detailed at the

American Heart Association scientific meeting in New Orleans,

the injected drug cut the risk of a first heart attack by 36%.

The results mark the first time a drug in a class known as

PCSK9 inhibitors was proven to be effective in primary

prevention, opening its use to more patients, Amgen ( AMGN ) research and

development chief Jay Bradner said in an interview.

Repatha also reduced the relative risk of cardiovascular

death by 21% in the trial, although that result was not deemed

statistically significant.

The U.S. Food and Drug Administration in August broadened

Repatha's approval to include adults at increased risk of major

cardiovascular events due to uncontrolled "bad" LDL cholesterol,

removing a prior requirement for a patient to be diagnosed with

cardiovascular disease.

"Having the label is wonderful, but having the data is

important," Bradner said, noting that health insurers and other

payers need those details for determining coverage.

Repatha targets PCSK9, a protein that maintains LDL

cholesterol in the blood, and helps people who don't benefit

from older statin pills, which block the liver's production of

bad cholesterol.

Sales of the drug, first approved in 2015, grew 33% from a

year earlier to total $2.15 billion in the first nine months of

2025.

Amgen ( AMGN ) last month launched direct-to-consumer sales of

Repatha for U.S. cash-paying patients at $239 a month, or nearly

60% below the drug's $573 list price.

Rivals are developing PCSK9 pills. Merck ( MRK ) will

present later at the AHA meeting data on its experimental daily

oral drug enlicitide decanoate, including results from a Phase 3

trial in adults with high cholesterol and a history of a major

cardiovascular event such as a heart attack or stroke.