The European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending approval for the marketing authorisation of Amgen‘s Repatha (evolocumab).
Evolocumab is an investigational fully human monoclonal antibody, for use in certain patients with high cholesterol.
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Repatha inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9), a protein that reduces the liver’s ability to remove low-density lipoprotein cholesterol (LDL-C) or bad cholesterol, from the blood.
The CHMP recommended granting Repatha marketing authorisation to treat adults with primary hypercholesterolemia or mixed dyslipidemia, as an adjunct to diet in combination with a statin or statin with other lipid-lowering therapies in patients unable to reach LDL-C goals with the maximum tolerated dose of a statin.
The drug is also recommended alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated.
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The marketing authorisation recommendation of Repatha was also for the treatment of adults and adolescents aged 12 years and above with homozygous familial hypercholesterolemia (HoFH) in combination with other lipid-lowering therapies.
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By GlobalDataAmgen Research and Development executive vice-president Sean Harper said: "We are pleased to receive a positive opinion from the CHMP for Repatha as it is an important step in providing a new treatment option for patients with high cholesterol, who are unable to reach their LDL cholesterol goals with current therapies in the European Union.
"Uncontrolled high cholesterol is a burden on the health system and we look forward to continuing to work with regulatory authorities to bring Repatha to patients across Europe."
The above-mentioned recommendation on granting of the marketing authorisation was also agreed by Icelandic and Norwegian CHMP members.
The European Commission (EC) will now review the CHMP positive opinion for Repatha and if approved, a centralised marketing authorisation with unified labelling will be granted in the 28 EU countries.
The positive opinion is based on data from approximately 6,800 patients, including more than 4,500 patients with high cholesterol in ten Phase III trials.
The trials evaluated the safety and efficacy of Repatha in patients with elevated cholesterol, including patients on statins with or without other lipid-lowering therapies; patients who cannot tolerate statins; patients with HeFH; and patients with HoFH, a rare and serious genetic disorder.
