Amgen’s Repatha wins PCSK9 heart drug race
pharmafile | July 21, 2015 | News story | Sales and Marketing | Amgen, European Commission, PCKS9, Repatha, evolocumab, high cholesterol
The European Commission has signed off on Amgen’s Repatha, making it the first in a new class of cholesterol-lowering drugs to be approved in the world.
The EC rubber-stamped Repatha (evolocumab), meaning Amgen has beaten rival firms Sanofi and Regeneron’s Praluent to become the first company to be given the go-ahead as a treatment for people with uncontrolled cholesterol who require additional intensive cholesterol drugs.
Repatha, an injection taken either every two weeks at a lower dose or once a month at a higher dose, is now approved in the 28 countries, and also shortly expected to be approved in Norway, Iceland and Liechtenstein. Praluent (alirocumab) is some way behind, although in June the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) of the FDA recommended it should be approved in the US.
Repatha is a human monoclonal antibody that inhibits PCSK9 (proprotein convertase subtilisin/kexin type 9), a protein that reduces the liver’s ability to remove LDL, or ‘bad’ cholesterol, from the blood. LDL cholesterol is a major risk factor for heart disease, however it is not yet clear if Repatha reduces the number of heart disease events or deaths from heart disease. The EC has approved Repatha on the basis of data on its effect on LDL cholesterol. The EMA recommended it for approval in June.
Amgen says that more than 60% of high-risk patients in Europe are still unable to adequately lower their LDL cholesterol levels with statins or other currently approved lipid-lowering agents. Among very high-risk patients, this figure is more than 80%. It estimates the health care cost of heart disease in the European Union at approximately €106 billion a year.
Sean Harper, executive vice president of R&D at Amgen, says: “We are proud that our cholesterol-lowering medication, Repatha, is the first PCSK9 inhibitor to be approved by any regulatory agency in the world.
“High LDL cholesterol is a major global health burden and many patients are unable to appropriately control their LDL cholesterol with the maximum tolerated dose of a statin, or are unable to take statins due to intolerance or contraindications. We are excited to make this new cholesterol-lowering medication available for patients in Europe.”
Lilian Anekwe
The EC approved Repatha 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 contraindicated.
- The treatment of adults and adolescents aged 12 years and over with homozygous familial hypercholesterolemia (HoFH) in combination with other lipid-lowering therapies.
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