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Amgen Astellas BioPharma K.K. (Headquarters, Tokyo; President and Representative Director: Steve Sugino, “Amgen Astellas”) today announced a revision to the prescribing information which includes clinical results and precautions for the hypercholesterolemia drug “Repatha® SC Injection 140 mg syringe and Repatha® SC Injection 140 mg Pen” and “Repatha® SC Injection 420 mg Auto Mini Doser (evolocumab (recombinant)),” (“Repatha®”). There has been no change to indications or to dosage and administration.
In the new revision, results of the 27,564-patient (including 429 Japanese patients) Repatha cardiovascular outcomes study (FOURIER) was added to the “clinical results” section of the Repatha® prescribing information due to the efficacy of Repatha® for the primary endpoint of cardiovascular event reduction in the treatment of hypercholesterolemia, as evidence supporting the indication for which Repatha® is approved.
The FOURIER study demonstrated that adding Repatha® to optimized statin therapy resulted in a statistically significant 20 percent (p<0.001) reduction compared to statin therapy alone in major adverse cardiovascular events (MACE) represented in the key (secondary) composite endpoint of time to first heart attack, stroke or cardiovascular death. The study found a statistically significant 15 percent reduction (p<0.001) in the risk of the extended MACE (primary) composite endpoint, which included hospitalization for unstable angina, coronary revascularization, heart attack, stroke or cardiovascular death. Similar results were found with Japanese patients. 1,2 For the secondary composite endpoint, an exploratory analysis showed a reduction in risk of 16 percent in the first year and 25 percent beyond the first year compared to statin therapy alone.
“In various clinical studies conducted to date, Repatha® has been proven to lower LDL cholesterol significantly,” said Masaharu Ishihara, Clinical Director of Coronary Heart Disease at the Hyogo College of Medicine Clinical Department and one of the foremost figures in the diagnosis and treatment of coronary artery disease. “The FOURIER study showed that it reduces cardiovascular events in Japanese patients with a history of myocardial infarction, stroke, or peripheral arterial disease. Past studies have shown that patients with a history of myocardial infarction, stroke, or peripheral arterial disease are at high risk of cardiovascular events. We are confident that adding the useful outcomes of the FOURIER study to the prescribing information and providing accurate knowledge to medical care professionals will be of benefit to patients.”
Repatha® was approved in the United States and Europe (US: December 2017, Europe: May 2018) as the first PCSK9 inhibitor to prevent heart attacks, strokes, and coronary revascularizations in adults with established cardiovascular disease based on the results of the FOURIER trial. In Japan, the evidence from the FOURIER data was assessed to be clinically significant and therefore was added to the preiscribing information.
Jointly developed by Amgen Astellas and Astellas, Repatha® is a human IgG2 monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9), a protein that reduces the liver's ability to remove LDL-C, or “bad” cholesterol, from the blood. 3 Repatha® was approved for the indication of familial hypercholesterolemia or hypercholesterolemia (only in patients with high risk of cardiovascular events and who do not adequately respond to HMG-CoA reductase inhibitors) in January 2016 and was launched in April of the same year in Japan. Additionally, in the drug price revision in April, the premium for true clinical utility (5% premium) was applied to Repatha® on the basis of the FOURIER study results.
About Amgen Astellas BioPharma
Amgen Astellas BioPharma K.K.（http://www.aabp.co.jp/jp/） is a Japanese company that began operations on October 1, 2013, to provide breakthrough-science-based medicines to help address unmet medical needs of patients in Japan. The company is a joint venture between Amgen, one of the world’s leading independent biotechnology companies, and Astellas Pharma Inc., a leading Tokyo-based R&D oriented global pharmaceutical company.
AABP has grown into an organization with over 400 employees and comprehensive functions to be fully operational as a marketing authorization holder in Japan. The joint venture will become a wholly-owned Amgen affiliate as soon as 2020.
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
For more information, visit www.amgen.com and follow us on www.twitter.com/amgen.
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References (related documents)
For information on this matter contact:
Corporate Affairs, Amgen Astellas BioPharma K.K. (TEL +81-3-5293-9694)