European Commission approves evolocumab for LDL reduction

Amgen has announced that it has received marketing authorization from the European Commission for evolocumab, a PCSK9 inhibitor.

The drug, to be marketed as Repatha (Amgen), is the first PCSK9 inhibitor to be approved for intensive reduction of LDL, according to a company press release. The approval allows Amgen to market the drug in 28 countries that comprise the European Union.

Evolocumab has been approved by the European Commission for the treatment of adults with primary hypercholesterolemia or mixed dyslipidemia, either alone or in combination with statins and/or other lipid-lowering therapies, and for the treatment of patients aged 12 years or older with homozygous familial hypercholesterolemia, in combination with other lipid-lowering agents, according to the release.

The approval follows results from a clinical study in approximately 6,000 patients, in which evolocumab reduced LDL by 55% to 75% compared with placebo in patients with elevated cholesterol, and by 15% to 30% in patients with homozygous familial hypercholesterolemia. The impact of evolocumab on CV morbidity and mortality has yet to be determined, according to the release.

“As the first in a new class of drugs in the European Union, evolocumab will offer physicians an important and innovative treatment option for patients with uncontrolled cholesterol who require additional LDL cholesterol reduction,” John J.P. Kastelein, MD, MPH, professor of medicine and chairman of the department of vascular medicine at the Academic Medical Center of the University of Amsterdam, stated in the release.

Evolocumab is currently under priority review by the FDA in the United States. The agency has a target action date of August 27, 2015, under the Prescription Drug User Fee Act.

Disclosure: Kastelein reports receiving consultant fees/honoraria from Amgen and numerous other pharmaceutical and device companies.