Amgen today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency(EMA) has adopted a positive opinion for the marketing authorization of Repatha (evolocumab) recommending approval for use in certain patients with high cholesterol. Repatha is an investigational fully human monoclonal antibody that 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 authorization for: 

• The treatment of adults with primary hypercholesterolemia (heterozygous familial and non-familial [HeFH]) 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, or alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contra-indicated.
• The treatment of adults and adolescents aged 12 years and over with homozygous familial hypercholesterolemia (HoFH) in combination with other lipid-lowering therapies. 

The effect of Repatha on cardiovascular morbidity and mortality has not yet been determined.

"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," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "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."

For more details, go to: http://www.amgen.com/media/media_pr_detail.jsp?releaseID=2052739