peginesatide成为美国第一个用于治疗接受透析的慢性肾脏病患者贫血的药物
来源：http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm297464.htm
Peginesatide是由Affymax和武田药品工业公司(Takeda Pharmaceutical Company)合作研发的，是一种合成的聚乙二醇肽，可以结合和激活促红细胞生成素受体,因此同红细胞生成刺激药物一样起治疗作用，可用于治疗接受透析的慢性肾脏病(chronic kidney disease，简称CKD)患者贫血。临床研究报告中最常见的不良反应为腹泻、咳嗽、呼吸困难、恶心和肌肉痉挛。
美国最新消息，生物制药公司Affymax近日宣布此前向欧洲药品局(European Medicines Agency，简称EMA)提交的peginesatide营销授权申请目前已获得批准。
Affymax和武田药品工业公司此前已签署了一项全球独家协议，Affymax和武田公司将共同负责peginesatide在美国市场上的商业化运作。武田公司从Affymax公司获得了依销售量缴付权利金的独家许可经营权，在包括日本在内的美国以外市场开发和销售peginesatide。Affymax公司将负责生产peginesatide所用的原料药，而此次营销授权申请获得批准，Affymax公司将获得500万美元的里程碑付款。
据悉，美国食品和药物管理局(Food and Drug Administration，简称FDA) 已接受了Affymax公司关于peginesatide的新药上市申请，美国处方药付费方案(Prescription Drug User Fee Act，简称PDUFA)要求美国食品和药物管理局关于peginesatide的审评决定时期为2012年3月27日。peginesatide成为美国第一个用于治疗接受透析的慢性肾脏病患者贫血的药物。
FDA approves Omontys to treat anemia in adult patients on dialysis
The U.S. Food and Drug Administration today approved Omontys (peginesatide) to treat anemia, a condition in which the body does not have enough healthy red blood cells, in adult dialysis patients who have chronic kidney disease (CKD).
Omontys is a new erythropoiesis-stimulating agent (ESA) that aids in the formation of red blood cells. It works by stimulating the bone marrow to produce more red blood cells, usually measured as hemoglobin levels, to reduce the need for transfusions in patients with CKD. Omontys is administered as a once-a-month injection.
“Omontys represents the first new FDA-approved and marketed ESA for this condition since 2001,” said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “This new drug offers patients and health care providers the convenience of receiving ESA therapy just once per month instead of more frequent injections.”
Two randomized, active-controlled, open-label, multi-center clinical trials demonstrated the safety and efficacy of Omontys in patients with CKD who were on dialysis. The trials randomly selected a total of 1,608 patients with hemoglobin levels initially stabilized by ESA to receive either Omontys once monthly or to continue their current ESA (epoetin) treatment. Results showed Omontys was as safe and effective as epoetin in maintaining hemoglobin levels within the studies’ pre-specified range of 10 to 12 grams per deciliter.
The most common side effects observed in 10 percent or more of dialysis patients treated with Omontys were diarrhea, vomiting, high blood pressure (hypertension) and joint, back, leg or arm pain (arthralgia).
Omontys should not be used in patients with CKD who are not receiving dialysis or in patients with cancer–related anemia, according to the FDA-approved labeling. It also should not be used as a substitute for red blood cell transfusions in patients who require immediate correction of anemia. Omontys has not been shown to improve symptoms of anemia, physical functioning or health-related quality of life in patients with CKD on dialysis.
The FDA approved Omontys with a Risk Evaluation and Mitigation Strategy (REMS), which added safety measures consisting of educational elements for health care professionals and a requirement to assess drug use data.
Omontys is marketed by Affymax Inc. of Palo Alto, Calif.
For more information:
For more information:
FDA: Office of Hematology and Oncology Products1FDA: Approved Drugs: Questions and Answers2The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
2012年3月27日，安进（Amgen）公司终于失去了对美国抗贫血药物市场的控制权。今天中午，FDA宣布Affymax公司药物peginesatide审批通过。Peginesatide作为一种促红细胞生成刺激剂（erythropoiesis-stimulating agents，ESAs）药物，将以商品名Omontys出售。该审批为药物Epogen的竞争对手进入市场铺平了道路，为患者提供了一种更便利的给药方案。Epogen是安进（Amgen）公司经久不衰的贫血症重磅炸弹。
Peginesatide最大的优势在于，患者只需每月注射一次；而对于Epogen，则需每月注射多达12次。 2 1 2 下一页 尾页
来源：http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm297464.htm
Peginesatide是由Affymax和武田药品工业公司(Takeda Pharmaceutical Company)合作研发的，是一种合成的聚乙二醇肽，可以结合和激活促红细胞生成素受体,因此同红细胞生成刺激药物一样起治疗作用，可用于治疗接受透析的慢性肾脏病(chronic kidney disease，简称CKD)患者贫血。临床研究报告中最常见的不良反应为腹泻、咳嗽、呼吸困难、恶心和肌肉痉挛。
美国最新消息，生物制药公司Affymax近日宣布此前向欧洲药品局(European Medicines Agency，简称EMA)提交的peginesatide营销授权申请目前已获得批准。
Affymax和武田药品工业公司此前已签署了一项全球独家协议，Affymax和武田公司将共同负责peginesatide在美国市场上的商业化运作。武田公司从Affymax公司获得了依销售量缴付权利金的独家许可经营权，在包括日本在内的美国以外市场开发和销售peginesatide。Affymax公司将负责生产peginesatide所用的原料药，而此次营销授权申请获得批准，Affymax公司将获得500万美元的里程碑付款。
据悉，美国食品和药物管理局(Food and Drug Administration，简称FDA) 已接受了Affymax公司关于peginesatide的新药上市申请，美国处方药付费方案(Prescription Drug User Fee Act，简称PDUFA)要求美国食品和药物管理局关于peginesatide的审评决定时期为2012年3月27日。peginesatide成为美国第一个用于治疗接受透析的慢性肾脏病患者贫血的药物。
FDA approves Omontys to treat anemia in adult patients on dialysis
The U.S. Food and Drug Administration today approved Omontys (peginesatide) to treat anemia, a condition in which the body does not have enough healthy red blood cells, in adult dialysis patients who have chronic kidney disease (CKD).
Omontys is a new erythropoiesis-stimulating agent (ESA) that aids in the formation of red blood cells. It works by stimulating the bone marrow to produce more red blood cells, usually measured as hemoglobin levels, to reduce the need for transfusions in patients with CKD. Omontys is administered as a once-a-month injection.
“Omontys represents the first new FDA-approved and marketed ESA for this condition since 2001,” said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “This new drug offers patients and health care providers the convenience of receiving ESA therapy just once per month instead of more frequent injections.”
Two randomized, active-controlled, open-label, multi-center clinical trials demonstrated the safety and efficacy of Omontys in patients with CKD who were on dialysis. The trials randomly selected a total of 1,608 patients with hemoglobin levels initially stabilized by ESA to receive either Omontys once monthly or to continue their current ESA (epoetin) treatment. Results showed Omontys was as safe and effective as epoetin in maintaining hemoglobin levels within the studies’ pre-specified range of 10 to 12 grams per deciliter.
The most common side effects observed in 10 percent or more of dialysis patients treated with Omontys were diarrhea, vomiting, high blood pressure (hypertension) and joint, back, leg or arm pain (arthralgia).
Omontys should not be used in patients with CKD who are not receiving dialysis or in patients with cancer–related anemia, according to the FDA-approved labeling. It also should not be used as a substitute for red blood cell transfusions in patients who require immediate correction of anemia. Omontys has not been shown to improve symptoms of anemia, physical functioning or health-related quality of life in patients with CKD on dialysis.
The FDA approved Omontys with a Risk Evaluation and Mitigation Strategy (REMS), which added safety measures consisting of educational elements for health care professionals and a requirement to assess drug use data.
Omontys is marketed by Affymax Inc. of Palo Alto, Calif.
For more information:
For more information:
FDA: Office of Hematology and Oncology Products1FDA: Approved Drugs: Questions and Answers2The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
2012年3月27日，安进（Amgen）公司终于失去了对美国抗贫血药物市场的控制权。今天中午，FDA宣布Affymax公司药物peginesatide审批通过。Peginesatide作为一种促红细胞生成刺激剂（erythropoiesis-stimulating agents，ESAs）药物，将以商品名Omontys出售。该审批为药物Epogen的竞争对手进入市场铺平了道路，为患者提供了一种更便利的给药方案。Epogen是安进（Amgen）公司经久不衰的贫血症重磅炸弹。
Peginesatide最大的优势在于，患者只需每月注射一次；而对于Epogen，则需每月注射多达12次。 2 1 2 下一页 尾页