Amgen Receives NMPA Approval For Repatha (evolocumab) In China To Reduce The Risk Of Cardiovascular Events
THOUSAND OAKS, Calif, Amgen?(NASDAQ:AMGN) today announced that the?National Medical Products Administration?(NMPA) has approved a new indication for Repatha??(evolocumab) as the first PCSK9 inhibitor in?China?for adults with established atherosclerotic cardiovascular disease (ASCVD) to reduce the risk of myocardial infarction, stroke and coronary revascularization.
Low-density lipoprotein cholesterol (LDL-C) is one of the key modifiable risk factors for the development of cardiovascular disease.1,2?Decades of studies have demonstrated that reductions in cardiovascular risk are proportional to absolute reductions in LDL-C levels, making LDL-C the primary treatment target for the reduction of cardiovascular events.3,4?Yet, even among patients with cardiovascular disease currently taking a lipid-lowering therapy, many still do not meet recommended LDL-C goals and remain at risk for cardiovascular events.5?
Repatha?is an innovative biologic medicine proven to effectively lower LDL-C. It inhibits circulating proprotein convertase subtilisin/kexin type 9 (PCSK9) from binding to LDL receptors (LDLR). By inhibiting the binding of PCSK9 to LDLR, Repatha increases the number of LDLRs available to clear LDL from the blood, thereby significantly lowering LDL-C levels, and further preventing the risk of myocardial infarction and stroke.6
"The new expanded label in?China?is an important milestone providing high-risk patients, who are unable to control their LDL-C with statin therapy alone, with a new treatment option to help prevent life-changing heart attacks and strokes," said?Murdo Gordon, executive vice president of Global Commercial Operations at?Amgen. "This is also an important step for?Amgen?as we continue to bring innovative medicines to?China?and build our presence."
The approval of the extended label recognizes the positive findings from the 27,564-patient Repatha cardiovascular outcomes study (FOURIER). Compared to placebo plus statin therapy, patients on Repatha in combination with statin therapy, experienced a reduction in the risk of heart attack by 27 percent, the risk of stroke by 21 percent and the risk of coronary revascularization by 22 percent, accruing through the median 26 months of the study.7?Moreover, the results from a FOURIER subanalysis demonstrated consistent efficacy and safety in the reduction of cardiovascular events using Repatha in Asian populations versus those from non-Asian backgrounds.8
"Cardiovascular disease has become one of the greatest health challenges facing Chinese citizens today," said Professor?Changsheng Ma,?Beijing Anzhen Hospital,?Capital Medical University. "High levels of LDL-C have been proven to increase the risk of developing ASCVD. If such levels of LDL-C fail to be managed, patients will become increasingly susceptible to strokes and heart attacks. However, existing therapies have limitations and many patients fail to effectively control their LDL-C levels to prevent recurrent cardiovascular events. The approval of this new indication offers hope for patients who continue to struggle with achieving lower LDL-C levels, providing another treatment against cardiovascular events."
On?July 31, 2018, Repatha was approved by the NMPA as the first PCSK9 inhibitor in?China?for the treatment of adults and adolescents over 12 years old with homozygous familial hypercholesterolemia (HoFH).
About Repatha??(evolocumab)
Repatha is a human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9). Repatha binds to PCSK9 and inhibits circulating PCSK9 from binding to the low-density lipoprotein (LDL) receptor (LDLR), preventing PCSK9-mediated LDLR degradation and permitting LDLR to recycle back to the liver cell surface. By inhibiting the binding of PCSK9 to LDLR, Repatha increases the number of LDLRs available to clear LDL from the blood, thereby lowering LDL-C levels.6
Repatha is approved in more than 60 countries, including the U.S.,?Japan,?Canada?and in all 28 countries that are members of the?European Union. Applications in other countries are pending.
Repatha Cardiovascular Outcomes (FOURIER) Study Design
FOURIER (Further Cardiovascular OUtcomes Research?with PCSK9 Inhibition in subjects with Elevated Risk), a multinational Phase 3 randomized, double-blind, placebo-controlled trial, is designed to evaluate whether treatment with Repatha in combination with high- or moderate-intensity statin therapy compared to placebo plus statin therapy reduces cardiovascular events. The hard MACE composite endpoint is the time to cardiovascular death, myocardial infarction or stroke (key secondary endpoint). The extended MACE composite endpoint is the time to cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina or coronary revascularization (primary endpoint).
Eligible patients with high cholesterol (LDL-C =70 mg/dL or non-high-density lipoprotein cholesterol [non-HDL-C] =100 mg/dL) and established cardiovascular disease at more than 1,300 study locations around the world were randomized to receive Repatha subcutaneous 140 mg every two weeks or 420 mg monthly plus high- or moderate-intensity effective statin dose; or placebo subcutaneous every two weeks or monthly plus high- to moderate-intensity statin dose. Statin therapy was defined in the protocol as at least atorvastatin 20 mg or equivalent daily with a recommendation for at least atorvastatin 40 mg or equivalent daily where approved. The study was event driven and continued until at least 1,630 patients experienced a key secondary endpoint.
Important China Product Information
Repatha is indicated in adults with established atherosclerotic cardiovascular disease to reduce the risk of myocardial infarction, stroke, and coronary revascularization:
- in combination with the maximum tolerated dose of a statin with or without other lipid-lowering therapies or,
- alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated.
- to reduce the risk of myocardial infarction, stroke, and coronary revascularization in adults with established cardiovascular disease.
- as an adjunct to diet, alone or in combination with other lipid-lowering therapies (e.g., statins, ezetimibe), for treatment of adults with primary?hyperlipidemia (including heterozygous familial hypercholesterolemia [HeFH]) to reduce low-density lipoprotein cholesterol (LDL-C).
- as an adjunct to diet and other LDL-lowering therapies (e.g., statins, ezetimibe, LDL apheresis) in patients with homozygous familial hypercholesterolemia (HoFH) who require additional lowering of LDLC.