5 June 2017 - Amgen today announced the submission of a supplemental biologics license application to the U.S. FDA and a variation to the marketing authorisation to the EMA for Repatha (evolocumab), a PCSK9 inhibitor. 

The regulatory submissions are based on the 27,564-patient Repatha cardiovascular outcomes study (FOURIER), which showed that maximally reducing low-density lipoprotein cholesterol levels with Repatha, beyond what is possible with the current best therapy alone, leads to a further reduction in major cardiovascular events, including heart attacks, strokes and coronary revascularisations.

The Repatha cardiovascular outcomes study demonstrated that adding Repatha to optimized statin therapy resulted in a statistically significant 20% (p<0.001) reduction in hard major adverse cardiovascular events (MACE) represented in the composite (secondary) endpoint of time to first heart attack, stroke or cardiovascular death. The study found a statistically significant 15% reduction (p<0.001) in the risk of the extended MACE composite (primary) endpoint, which included hospitalisation for unstable angina, coronary revascularisation, heart attack, stroke or cardiovascular death.

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