FDA agrees to review Amgen’s PCSK9 inhibitor

Biotechnology company Amgen has received priority review from the U.S. Food and Drug Administration (FDA) for its PCSK9 inhibitor, Repatha.

The U.S. Prescribing Information for Repatha, if approved by the FDA, will include risk reduction of major cardiac events, according to a July 27 press release.

Priority review is given to applications for drugs that treat complicated conditions.

“The FDA’s decision to grant priority review for the Repatha cardiovascular outcomes data highlights the urgency to address the need to reduce heart attacks and strokes in high-risk patients who struggle to lower their LDL cholesterol,” said Sean E. Harper, MD, executive vice president of Research and Development at Amgen, in a statement. “We look forward to working with the FDA to update the label for Repatha enabling us to more broadly educate physicians and patients of the proven impact of Repatha to reduce cardiovascular events.”

In the FOURIER trial, results showed that adding Repatha to optimized statin therapy provided a 20 percent reduction in adverse cardiovascular events. There were more than 27,000 patients in the study. It was originally presented at the American College of Cardiology scientific sessions in March and was published in the New England Journal of Medicine.

Patients on Repatha experienced a reduction in risk for heart attack by 27 percent, a 21 percent reduction in stroke risk and a 22 percent reduction in coronary revascularization.

No new safety concerns were identified in the trial.