Amgen's cholesterol drug Repatha (evolocumab) has been approved by the US Food and Drug Administration (FDA) to prevent heart attacks, strokes and coronary revascularizations in adults having cardiovascular disease.
Evolocumab is the first PCSK9 inhibitor to receive this indication.
Repatha is available as a 140mg/mL strength prefilled syringe or SureClick autoinjector for subcutaneous (SC) injection as well as a 420mg/3.5mL strength Repatha Pushtronex system, an on-body infusor with prefilled cartridge. It has always maintained that the slow take-up has been caused by a reluctance by healthcare payers to fund treatment with the drug based on cholesterol-lowering data alone. The approval will allow Amgen to start promoting Repatha's ability to reduce heart attacks and strokes with both physicians and patients in the US.
Amgen CEO Robert Bradway said a few weeks ago that "improving patient access to Repatha remains a top priority for our team", adding that the cardiovascular outcomes data will be a key factor in that effort.
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In a phase 3 trial named as FOURIER that enrolled 27,564 patients, Repatha was demonstrated to have lowered the risk of heart attack by 27%, the risk of stroke by 21% and the risk of coronary revascularization by 22%.
Amgen Global Commercial Operations executive vice president Anthony Hooper said: "In the US, every 40 seconds someone has a heart attack or stroke, and almost one in three of these patients will have another event, leading to a societal cost that exceeds $600 billion annually".
"With this approval, it's now more important than ever that appropriate patients obtain access to Repatha in order to avoid preventable heart attacks and strokes". Amgen also provides patient assistance for its medicines marketed in the U.S.in a variety of ways, including free medicines through The Amgen Safety Net Foundation for qualifying individuals with no or limited drug coverage. The extended MACE composite endpoint is the time to cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina or coronary revascularization (primary endpoint). The trial included 27,564 patients with high cholesterol and established cardiovascular disease and a median follow-up period of 2.2 years.
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