[angio]

Evolocumab (Repatha, Amgen), an investigational human monoclonal antibody for proprotein convertase subtilisin-kexin type 9 (PCSK9), is one step closer to being available in Europe.
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approving evolocumab as an adjunct to diet in patients with elevated cholesterol levels who are unable to reach their recommended LDL-cholesterol goal despite taking an optimal dose of statin. Patients deemed statin intolerant or those in whom a statin is contraindicated would also be eligible for treatment with evolocumab.

The committee also recommended that the PCSK9 inhibitor, the first in its class to receive a positive opinion from CHMP, be available to treat patients with homozygous familial hypercholesterolemia (FH).

he PCSK9 inhibitor was considered safe based on data from more than 6000 patients followed for at least 6 months and more than 1100 patients followed for at least 2 years.

"Available evidence does not yet allow the longer-term benefits of Repatha for patients in reducing heart disease or death from heart disease to be determined," states the EMA.

The Further Cardiovascular Outcomes Research with PCSK9 Inhibition in Subjects with Elevated Risk (FOURIER) study is a 22,500-patient trial testing evolocumab against statin therapy for the reduction of the primary composite end point of cardiovascular death, MI, hospitalization for unstable angina, stroke, or coronary revascularization. Although ongoing, full results won't be available until 2017 at the earliest.

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