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糖尿病注射剂Bydureon(艾塞那肽缓释注射混悬剂)获美国FDA批准一周一次
2014-12-29 16:18:56 来源: 作者: 【 】 浏览:870次 评论:0
1月27日,美国食品药品监督管理局最终批准Amylin制药公司的糖尿病治疗药物Bydureon,该药通过一周注射使用一次来控制2型糖尿病患者的血糖。2010年,FDA两次拒绝了关于该药的申请,要求公司对药物在心脏节律影响上重新进行试验。
该公司形容Bydureon(艾塞那肽缓释注射混悬剂)是史无前例的,它是 Byetta 药物一周使用一次的版本,该公司生产糖尿病治疗药 Byetta 已有7年之久,且Byetta 需要每2天注射一次。
该药是一种胰高血糖素样肽-1(GLP-1)受体兴奋剂 ,获得批准以结合饮食和运动来改善2型糖尿病成年人的血糖控制。该公司称该药2月份将会在美国各药店上市销售。
医学专家,糖尿病护理中心主任,北卡罗来纳大学教堂山分校医学院 内分泌学部主任John Buse博士发表声明说,Bydureon使医生和他们的病人现在有更多的治疗选择,可以仅一周使用一次药物来长期地控制血糖。
“新的治疗选择对数百万不断努力使能最好地控制血糖的2型糖尿病成年人来说是十分重要的。”Buse说道。
为了获得批准,该公司提交Bydureon药物长期临床试验所获得的安全、有效的数据,这些试验由每2天使用一次的注射剂Byetta (艾塞那肽)临床试验作为基础。
Byetta已经在全球将近80个国家使用,自2005年起在美国上市销售。
Bydureon利用Alkermes的专有技术在一周的时间里控制艾塞那肽的释放。
Amylin公司表示,在长期试验中,Bydureon相对Byetta全面进行了24周的测试。结果显示,使用Bydureon的患者在统计A1C减少的数据上优于基点1.6个百分点,相比之下,使用Byetta 的患者只有0.9个百分点。(A1C 用来衡量3个月的平均血糖。)
研究的最后,两组试验均得到体重减轻这个重要的数据,这也是试验终点的另一个指标。(使用Bydureon的患者平均减轻5.1磅,2.3kg;使用Byetta 的患者平均减轻3.0磅,1.4kg)
两组中最常见的不良反应是恶心,与使用Byetta 的患者(35%)相比,使用Bydureon的患者(14%)更少出现该反应。
根据Amylin公司表示,使用Bydureon的患者出现的其它不良反应有腹泻,上呼吸道感染和注射部位结节,没有严重的低血糖事件。
该新药已经风险评估和减轻策略 (REMS) 批准,确保利益大于急性胰腺炎的风险和甲状腺髓样癌的潜在风险。
根据上市后的数据显示,艾塞那肽与急性胰腺炎有关,包括致命的和非致命性出血或坏死性胰腺炎。在动物研究上,Bydureon导致大鼠甲状腺瘤的生成,有些会发展为癌症。
Amylin公司称它也将达到“大量药品上市后的需要,进一步评估Bydureon对甲状腺髓样癌和心血管疾病的影响
 

Inject BYDUREON under the skin (subcutaneously), not into a muscle or a vein. You can administer the injection in your stomach area (abdomen), your thigh, or the back of your upper arms. Each week you can use the same general area of your body. Just be sure not to inject in the exact same place.
You may notice itching or redness at the injection site. Serious injection-site reactions, with or without bumps (nodules), have happened in some people who use BYDUREON. Some of these injection-site reactions have required surgical intervention. Call your healthcare provider right away if you have severe pain, swelling, blisters, an open wound, or a dark scab at your injection site.

Important Safety Information for BYDUREON® (exenatide extended-release for injectable suspension)
•POSSIBLE THYROID TUMORS, INCLUDING CANCER: In animal studies, BYDUREON caused rats to develop tumors of the thyroid gland. Some of these tumors were cancer. It is not known if BYDUREON causes thyroid tumors or a type of thyroid cancer called medullary thyroid cancer (MTC) in people. Do not use BYDUREON if you or any of your family members have MTC or if you have Multiple Endocrine Neoplasia syndrome type 2. While using BYDUREON, tell your healthcare provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer.
•Do not use BYDUREON if you have had an allergic reaction to exenatide or any of the other ingredients in BYDUREON. Severe allergic reactions can happen with BYDUREON. Symptoms of a severe allergic reaction to BYDUREON are severe rash or itching, swelling of your face, lips, and throat that may cause difficulty breathing or swallowing, feeling faint or dizzy, and very rapid heartbeat. If you have any symptoms of a severe allergic reaction, stop using BYDUREON and call your healthcare provider right away.
•Inflammation of the pancreas (pancreatitis) may happen, which may be severe and lead to death. Before using BYDUREON, tell your healthcare provider if you have had pancreatitis, stones in your gallbladder (gallstones), a history of alcoholism, or high blood triglyceride levels. Stop using BYDUREON and call your healthcare provider right away if you have pain in your stomach area (abdomen) that is severe and will not go away, occurs with or without vomiting, or is felt going from your stomach area through to your back. These may be symptoms of pancreatitis.
•Your risk for getting low blood sugar (hypoglycemia) is higher if you use BYDUREON with another medicine that can cause low blood sugar, such as a sulfonylurea. The dose of your sulfonylurea may need to be lowered while you use BYDUREON. Signs and symptoms of low blood sugar may include shakiness, headache, drowsiness, weakness, dizziness, confusion, irritability, hunger, fast heartbeat, sweating, and feeling jittery.
•Tell your healthcare provider if you have or had kidney problems or a kidney transplant. BYDUREON may cause nausea, vomiting, or diarrhea, leading to loss of fluids (dehydration). Dehydration may cause kidney failure; this can happen in people who have never had kidney problems before. Call your healthcare provider right away if you have nausea, vomiting, or diarrhea that will not go away or if you cannot drink liquids.
•Tell your healthcare provider if you have severe problems with your stomach, such as delayed emptying of your stomach (gastroparesis) or problems with digesting food.
•Serious injection-site reactions, with or without bumps (nodules), have happened in some people who use BYDUREON. Some of these injection-site reactions have required surgical intervention. Call your healthcare provider right away if you have severe pain, swelling, blisters, an open wound, or a dark scab at your injection site.
•The most common side effects with BYDUREON include nausea, diarrhea, headache, vomiting, constipation, itching at injection site, a small bump (nodule) at the injection site, and indigestion. Nausea most commonly happens when first starting BYDUREON, but may become less over time.
•Before using BYDUREON, tell your doctor about all the medicines you use, as using them with BYDUREON may affect how each medicine works. Tell your healthcare provider if you use other diabetes medicines, especially insulin or a sulfonylurea, or warfarin sodium (Coumadin® or Jantoven®).
•Tell your healthcare provider if you are pregnant or plan to become pregnant. It is not known if BYDUREON will harm your unborn baby. Talk to your healthcare provider first if you are breastfeeding or plan to breastfeed.
Approved Uses
BYDUREON is an injectable prescription medicine that may improve blood sugar (glucose) in adults with type 2 diabetes mellitus, and should be used along with diet and exercise. BYDUREON is not recommended as the first medication to treat diabetes.
BYDUREON is a long-acting form of the medication in BYETTA® (exenatide) injection so both drugs should not be used together. BYDUREON is not a substitute for insulin and has not been studied in combination with insulin. BYDUREON is not for people with type 1 diabetes or people with diabetic ketoacidosis (a condition caused by very high blood sugar). BYDUREON is not recommended for use in children. It is not known if BYDUREON is safe and effective in people with a history of pancreatitis or severe kidney problems.
Please read full Prescribing Information , including Boxed WARNING about possible thyroid tumors including thyroid cancer, Instructions for Use , and Medication Guide  for BYDUREON 2 mg.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
 

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