More Positive Outcomes for PCSK9 Inhibitor

In results of a major study to be presented at the upcoming American College of Cardiology (ACC) 66th Annual Scientific Sessions' late-breaking clinical trials March 17, researchers had more good news about a PCSK9 inhibitor.

A phase 3 study called FOURIER showed that patients who took evolocumab (Repatha/Amgen) showed that high-risk patients who had already had a heart attack, ischemic stroke, of symptomatic peripheral artery disease and were taking statins to control LDL cholesterol had fewer adverse cardiac events than controls taking statins.

A second study of Repatha's effects on cognition will also be reported at the meeting on March 18. The company said that the cognition study, called EBBINGHAUS, showed the drug is non-inferior to statins.

The FOURIER study involved 27,500 patients and was multi-national.

The subjects were randomized to get an injection of Repatha either at a dosage of 140 mg every two weeks or 420 mg monthly. Control groups got placebo injections at the same doses.

The study continued until at least 1,630 patients had a secondary major adverse cardiac event, died, had a heart attack, or a stroke.

Repatha is already approved in more than 40 countries, including the United States.

"No new safety issues were observed," Amgen said in a news release.

Amgen is withholding full details of the studies until the ACC meeting.