EMA Committee Recommends Approval of Evolocumab

LONDON, UK — 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[1].

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).

The drug, which requires a subcutaneous injection every 2 or 4 weeks depending on the dose, works by blocking the PCSK9 protein. PSCK9 limits the number of LDL receptors available in the liver and reduces the body's ability to remove LDL cholesterol from the bloodstream.

In a press release, the EMA said the positive review from CHMP is based on the efficacy of evolocumab for lowering LDL-cholesterol levels in nine studies of patients with hypercholesterolemia/mixed dyslipidemia and in two studies of patients with homozygous FH. The 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.

The positive opinion from CHMP is the first step toward widespread availability in the European Union. The positive recommendation from the committee will now be sent to the European Commission, which will make the final decision on approving the agent.

On June 10, 2015, an advisory committee from the US Food and Drug Administration will evaluate the safety and efficacy data for evolocumab and make its own recommendation about the drug's availability stateside. The day prior, the same FDA advisory committee will evaluate alirocumab (Praluent, Sanofi/Regeneron Pharmaceuticals), another PCSK9 inhibitor similar to evolocumab that is currently being reviewed by European regulatory authorities.

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