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Medicines licensing

PCSK9 inhibitor evolocumab gets green light for European approval

Europe’s medicines regulator has given its seal of approval to evolocumab, a monoclonal antibody for treating high cholesterol.

The first monoclonal antibody for treating high cholesterol and the first PCSK9 inhibitor is set to launch following a positive opinion from the European Medicines Agency. In the image, a magnification of cholesterol crystals (25x)

Source: PHOTOTAKE Inc. / Alamy

Patients with high cholesterol (cholesterol crystals X25 magnification pictured) could benefit from evolocumab, a PCSK9 inhibitor, which is set to launch in Europe

The first monoclonal antibody for treating high cholesterol and the first PCSK9 inhibitor is set to launch following a positive opinion from the European Medicines Agency (EMA).

Evolocumab (Repatha), an inhibitor of proprotein convertase subtilisin/kexin type 9 (PCSK9), was recommended at the May 2015 meeting of the EMA’s Committee for Medicinal Products for Human Use (CHMP) as a treatment for people with primary hypercholesterolaemia who are unable to control their cholesterol with current therapies, including maximum statin doses.

Repatha is also an option for people aged 12 years and older with homozygous familial hypercholesterolaemia (FH), a rare inherited disorder that causes lifelong, dramatic elevations in low-density lipoprotein cholesterol (LDL-C) and early death from cardiovascular disease.

EU-wide marketing authorisation for Repatha, which was developed by Amgen, is expected to be granted within the next few months. The US Food and Drug Administration (FDA) is due to review data supporting Amgen’s licensing application on 10 June 2015.

Repatha inhibits PCSK9, a protein that reduces the liver’s ability to remove LDL-C from blood. Another PCSK9 inhibitor, Sanofi/Regeneron’s alirocumab (Praluent), is also set for FDA review in June 2015 while Pfizer’s bococizumab is in late-stage clinical development.

Repatha provides a new option for people who are unable to control their cholesterol levels with current treatments such as statins and other lipid-lowering drugs. It is also an alternative therapy for people who are statin-intolerant. It should be used in conjunction with an appropriate diet and other tolerated lipid-lowering therapies.

Repatha is the first biologic drug to be recommended for approval for the treatment of hypercholesterolaemia. In clinical trials, Repatha, which is injected fortnightly or monthly, reduced LDL-C in patients with hypercholesterolaemia and mixed dyslipidaemia as well as in those with homozygous FH.

In these trials, Repatha was generally well tolerated with a frequency of adverse events similar to placebo. The most commonly reported adverse drug reactions were inflammation of the nose and throat (4.8%), upper respiratory tract infection (3.2%), back pain (3.1%), arthralgia (2.2%), influenza (2.3%) and nausea (2.1%). Other adverse drug reactions detected based on medical review included rash, urticaria and injection site reactions (erythema, pain, bruising), and most were grade 1 or 2.

Trials evaluating the impact of Repatha treatment on the risk of cardiovascular disease and death are under way. Further data will be collected to assess the implications of very low cholesterol levels.

  • This article was amended on 4 June 2015 to clarify that Repatha has been recommended for approval but has not yet been granted marketing authorisation.

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2015.20068650

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Supplementary images

  • The first monoclonal antibody for treating high cholesterol and the first PCSK9 inhibitor is set to launch following a positive opinion from the European Medicines Agency. In the image, a magnification of cholesterol crystals (25x)

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