Amgen earns first Japanese nod for PCSK9 inhibitor
pharmafile | January 25, 2016 | News story | Sales and Marketing | Amgen, Astellas, Japan, PCSK9 inhibitor, Repatha, evolocumab, high cholesterol
The Japanese Ministry of Health, Labour and Welfare has approved Amgen’s cholesterol-lowering medication Repatha, in a joint venture between Amgen and the Japanese pharma company Astellas.
The decision means Repatha (evolocumab) injection becomes the first proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor to be approved in Japan. It is also approved in the European Union, United States and Canada.
In Japan, Repatha is indicated for the treatment of patients with familial hypercholesterolemia (FH) or hypercholesterolemia who have high risk of cardiovascular events and do not adequately respond to HMG-CoA reductase inhibitors (statins). It is estimated that heterozygous FH is the more common type of FH and in Japan, and occurs in approximately one in 500 individuals.
Today’s approval of Repatha, the first PCSK9 inhibitor approved in Japan, is an important milestone for patients and physicians who need additional treatment options to lower LDL cholesterol,” says Sean Harper, executive vice president of research and development at Amgen. “High LDL cholesterol is a modifiable risk factor for cardiovascular disease and many patients are unable to appropriately control their LDL cholesterol with statin therapy alone. We are excited to bring Repatha to patients in Japan and will continue to work with regulatory authorities to make this innovative medicine available to patients worldwide.”
While Eiichi Takahashi, general manager of the Amgen Astellas BioPharma joint venture, adds: “This approval is significant for patients and physicians in Japan and is a testament to the ongoing collaboration between Amgen and Astellas. We are proud of the progress we are making toward our common goal of addressing the critical needs of Japanese patients with high LDL cholesterol who struggle to control their condition.”
The decision comes shortly after Amgen also received another approval, for its cancer drug Kyprolis (carfilzomib), in a combination with dexamethasone for multiple myeloma.
“In Japan, LDL cholesterol levels are not adequately controlled for many patients who are at high risk of cardiovascular events and taking statins, nearly half of whom have not reached their desired LDL cholesterol goal,” says Dr Tamio Teramoto, director of Teikyo Academic Research Centre and an investigator for the Phase II YUKAWA-1 trial. “As the first in a new class of medicines in Japan, Repatha offers physicians an important treatment option for patients who require additional LDL cholesterol reduction.”
Lilian Anekwe
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