Amgen seeks market approval for Repatha in U.S., Europe

Thousand Oaks, California-based Amgen has submitted a supplemental Biologics License Application to the U.S. Food and Drug Administration (FDA) and a variation of one in Europe seeking approval for Repatha, a PCSK9 inhibitor.

The submission uses the FOURIER (Further Cardiovascular Outcomes Research with PCSK9 Inhibition in Subjects with Elevated Risk) trial to show that Repatha is effective in reducing low-density lipoprotein cholesterol levels beyond what is currently possible, according to a June 5 press release.

The trial was originally presented at the American College of Cardiology’s annual conference in Washington, D.C., in March. It was also published in the New England Journal of Medicine.

The study, which included more than 27,000 patients, revealed that adding Repatha to optimized statin therapy results in a 20 percent reduction in hard major adverse cardiovascular events in the composite endpoint, which included hospitalization for unstable angina, coronary revascularization, heart attack, stroke and cardiovascular death. No new safety concerns were identified in the trial and throughout its follow-up years.

"Despite optimized therapy, including high-intensity statins, patients in our landmark cardiovascular outcomes study were still at high risk for an additional cardiovascular event. This demonstrates a significant unmet need, as event rates in the real world are typically two to three times higher than those seen in clinical trial settings," said Sean E. Harper, MD, executive vice president of Research and Development at Amgen, in a statement. "These regulatory submissions are important steps forward to helping improve access for patients who remain at high risk for cardiovascular events. We look forward to working with the FDA and EMA to update the labels for Repatha."