FDA grants priority review for evolocumab CV outcomes indication

The FDA has granted a priority review of a supplemental Biologics License Application for a PCSK9 inhibitor, according to a statement from Amgen.

“The FDA’s decision to grant priority review for the Repatha (evolocumab) [CV] outcomes data highlights the urgency to address the need to reduce [MIs] and strokes in high-risk patients who struggle to lower their LDL cholesterol,” Sean E. Harper, MD, executive vice president of research and development at Amgen.

If approved, labeling information for Repatha will include risk reduction of major CV events, based on data from the FOURIER study.

In the FOURIER study, patients assigned Repatha with optimized statin therapy had a 20% reduction in major adverse CV events, defined as MI, stroke and CV death(P < .001), according to the statement. The risk for major adverse CV events, including CV death and hospitalization for stroke, coronary revascularization, MI and unstable angina, was also reduced by 15% (P < .001). Magnitude of risk reduction increased over time throughout a median of 2.2 years of follow up, according to the release.

Patients assigned evolocumab also saw decreases in the risk for stroke by 21% (nominal P = .01), MI by 27% (nominal P < .001) and coronary revascularization by 22 % (nominal P < .001) without an effect on CV mortality or hospitalization for unstable angina.

Along with the priority review, the FDA has also accepted an application to expand the lipid-lowering indication of the treatment to include additional patient populations, Amgen stated.

The date for the FDA to make a decision in accordance with Prescription Drug User Fee Act is December 2, 2017, according to the statement.

Disclosure: Harper is an employee of Amgen.