Amgen Inc.'s phase 3 drug trial for Repatha met its primary composite endpoint and the key secondary composite endpoint.
The trial evaluated whether the drug reduced the risk of cardiovascular events in patients with atherosclerotic cardiovascular disease, the buildup of plaque in arteries. It was designed to assess if treatment with Repatha in combination with statin therapy compared to placebo plus statin therapy reduces cardiovascular events.
The drug trial met the primary endpoint of time to cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization and the key secondary endpoint were the time to cardiovascular death, myocardial infarction or stroke.
In addition, the trial showed a link between lowering LDL cholesterol with Repatha and cardiovascular risk reduction, even in patients previously treated with optimized statin therapy.
No new safety issues were observed.
In addition, a second trial conducted in the patients of the first trial also achieved its primary endpoint, showing that Repatha was non-inferior to placebo for the effect on cognitive function.
Repatha is approved in more than 40 countries, including the U.S., Japan, Canada and in all 28 countries that are members of the EU.