FDA approves Amgen’s cholesterol lowering drug
pharmafile | August 28, 2015 | News story | Medical Communications, Research and Development | Amgen, FDA, Repatha, evolocumab
The FDA has endorsed Amgen’s cholesterol-lowering medication, Repatha, for the use in patients with high cholesterol.
It follows Amgen’s successful EU approval of Repatha (evolocumab) earlier in the summer.
The injectable drug is a human monoclonal antibody, which works by making the liver more efficient at getting rid of low-density lipoprotein cholesterol (LDL-C), or ‘bad’ cholesterol, from the blood.
Repatha is approved as an adjunct to diet for the treatment of adults with heterozygous familial hypercholesterolemia (HeFH), which is an inherited condition causing high cholesterol levels. The drug has also been approved for patients with clinical atherosclerotic cardiovascular disease (ASCVD), who require additional lowering of cholesterol.
It is available as a single-use prefilled SureClick auto-injector pen, or prefilled syringe that patients can self-administer every two weeks, or once a month in a higher dose. The FDA says the drug offers alternative treatment to patients who are not responding to current medication or are unable to take them due to side effects.
John Jenkins, the director of the FDA Office of New Drugs Center for Drug Evaluation and Research says: “Repatha provides another treatment option in this new class of drugs for patients with familial hypercholesterolemia or with known cardiovascular disease who have not been able to lower their LDL cholesterol enough with statins.
He went on to say: “Cardiovascular disease is a serious threat to the health of Americans, and the FDA is committed to facilitating the development and approval of effective and safe drugs to address this important public health problem.”
Sean Harper, executive vice president of research and development at Amgen says: “We are excited about the approval of Repatha in the US, as patients and physicians will now have a new treatment option to lower LDL cholesterol. Data from key clinical studies have shown that Repatha significantly reduces LDL cholesterol in patients who have not been able to lower their LDL cholesterol through diet and statins alone. At Amgen, we are committed to improving the lives of patients and are inspired by the potential for Repatha to aid in the global fight against one of the major risk factors for cardiovascular disease.”
In Phase III trials, adding Repatha to background lipid-lowering therapy that included statins resulted in intensive reductions in cholesterol levels with favourable effects. Repatha is expected to be available in the US next week.
Amgen faces a battle to price the biological drug competitively, particularly in comparison to generic statins, a point that Anthony Hooper, executive vice president of global commercial operations at Amgen, acknowledges.
“Amgen is sensitive to the concerns of payers around cost, budget predictability and paying for value,” Hooper says. “We are confident in the ability of Repatha to demonstrate real-world effectiveness and value based on intensive LDL cholesterol reductions, and we will be working with payers and other purchasers to provide innovative pricing programs linking the net price of Repatha to the expected LDL cholesterol reductions and anticipated appropriate patient utilization.
“By partnering with payers to implement these programs, we can help ensure that all appropriate patients who could benefit from Repatha will have access to this important new therapy.”
Yasmita Kumar
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