The Food and Drug Administration (FDA) has granted Priority Review for Amgen’s supplemental Biologics License Application (sBLA) of Repatha (evolocumab) to include a risk reduction for major adverse cardiovascular events (MACE) in the Prescribing Information.
Evolocumab is a human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9). The new sBLA is supported by data from the FOURIER study which assessed MACE outcomes in 27,564 patients who were randomized to receive either evolocumab in combination with statin therapy or placebo plus statin therapy. The median length of the study was 2.2 years.
Results showed that the evolocumab group had a statistically significant 15% reduction (P<0.001) in the risk of extended MACE composite (primary) endpoint – which included hospitalization for unstable angina, coronary revascularization, heart attack, stroke or cardiovascular death – compared to placebo group. For the secondary endpoint – time to first heart attack, stroke or cardiovascular death – the evolocumab plus statin group had a statistically significant 20% reduction (P<0.001) compared to the placebo group.
The risk reduction for both composite endpoints increased with time with benefits seen as soon as 6 months and growing through the median 2.2 years. There was no effect on cardiovascular mortality or on hospitalization for unstable angina. In addition, no new safety issues were noted in this trial.
In addition, a second application proposing an expanded lipid-lowering indication of other patient populations was also accepted by the FDA.
The FDA has set a Prescription Drug User Free Act (PDUFA) action date for the sBLA of December 2, 2017.
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