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糖尿病市场硝烟再起——FDA批准礼来GLP-1类糖尿病新药Trulicity

  1. dulaglutide
  2. GLP-1
  3. Trulicity
  4. 礼来
  5. 糖尿病

来源:生物谷 2014-09-21 09:41

礼来近日赢得一场大战,糖尿病新药Trulicity获FDA批准,该药每周一次,在临床中与诺和诺德年销20亿美元的每日一次Victoza疗效相当,GLP-1市场很快将硝烟再起!

2014年9月21日讯 /生物谷BIOON/ --导读:糖尿病GLP-1受体激动剂市场竞争异常激烈。四面楚歌的礼来终于赢得一场硬仗,新药Trulicity获FDA批准,临床中疗效媲美诺和诺德Victoza。Victoza年销20亿美元,在GLP-1市场傲视群雄,而Trulicity具有每周注射一次的优势,将成为Victoza的替代者。业界预测,Trulicity将成为糖尿病市场的重磅炸弹。

糖尿病新药开发已成为生物技术领域的重点,GLP-1(胰高血糖素样肽-1)受体激动剂尤受关注。GLP-1是一种重要的肠促胰岛素激素,帮助恢复正常的血糖水平。现在这个竞技场已变得“人头挤挤”,获准上市的有诺和诺德的Victoza(诺和力,通用名:利拉鲁肽),百时美施贵宝和阿斯利康的Byetta(百泌达,艾塞那肽)和Bydureon(艾塞那肽),以及赛诺菲的Lyxumia(利西拉肽)。此外,葛兰素史克(GSK)的GLP-1受体激动剂albiglutide也分别于2014年3月和4月获欧盟和FDA批准,品牌名分别为Epenzan和Tanzeum。

四面楚歌的礼来(Eli Lilly)近日终于赢得了一场大战,该公司研发的糖尿病新药Trulicity(dulaglutide)获得了FDA的批准,该药也属于GLP-1受体激动剂。此前,Trulicity的III期项目已被认为是礼来开辟新市场的最佳筹码,不过现在许多分析师仍不清楚,礼来如何才能在已经拥挤不堪的GLP-1市场中占得一席之地,尽管糖尿病市场巨大,同时该市场也正随着全球糖尿病浪潮不断增长。FDA药品评价和研究中心主任Mary Parks称,在2型糖尿病的综合管理中,Trulicity是一种新的治疗选择,可单独用药或添加到现有的治疗方案,帮助控制血糖水平。

礼来量身定制的9部分III期项目,将Trulicity与其最可能的竞争对手进行了头对头的研究,该药的表现也没让人失望。在临床研究中,Trulicity击败了阿斯利康的Byetta和默沙东的Januvia+二甲双胍疗法。同时,根据在美国糖尿病协会会议上公布的最新成果,Trulicity证明了相对于诺和诺德重磅药物Victoza的非劣效性,Victoza年销售额高达20亿美元,在GLP-1市场中傲视群雄。

Victoza每日注射一次,而Trulicity每周注射一次,这也是首次一种每周一次的GLP-1制剂在III期临床中达到每日一次的GLP-1制剂的效果,葛兰素史克(GSK)上半年获批的Tanzeum/Epenzan也是每周注射一次的GLP-1制剂。这将成为礼来营销Trulicity时的卖点,该药将成为Victoza更方便的替代者。

关于Trulicity的销售前景,有分析师预测其销售潜力为7亿美元,但也有分析师认为,鉴于该药相对于Victoza的便利性,其2020年销售将达到13亿美元。然而,这些数字都不足以弥补礼来所面临的专利损失,今年也将是礼来最艰难的一年,近期获批的其他产品,均不具有Trulicity的市场潜力。

FDA已批准Trulicity辅助饮食和运动,用于2型糖尿病成人患者的血糖控制,礼来计划于今年晚些时候,在美国推出Trulicity 0.75mg和1.5mg单剂量注射笔。此次获批,也标志着Trulicity的首个全球批准,目前,该药也正在接受欧洲药品管理局(EMA)和其他监管部门的审查。(生物谷Bioon.com)

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英文原文:FDA Approves Trulicity™ (dulaglutide), Lilly's Once-Weekly Therapy for Adults with Type 2 Diabetes

- Trulicity, a weekly glucagon-like peptide-1 (GLP-1) receptor agonist, is indicated for adults with type 2 diabetes as an adjunct to diet and exercise
- The single-dose pen does not require mixing nor measuring and comes with a no-see, no-handle needle

INDIANAPOLIS, Sept. 18, 2014 /PRNewswire/ -- Trulicity™ (dulaglutide), approved today by the U.S. Food and Drug Administration, is the latest Eli Lilly and Company (NYSE: LLY) treatment option for adults with type 2 diabetes.

Trulicity is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. Trulicity is not recommended as first-line therapy for patients inadequately controlled on diet and exercise. It has not been studied in patients with a history of pancreatitis, and other antidiabetic therapies should be considered for patients with a history of pancreatitis. Trulicity is not for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis. Trulicity is not a substitute for insulin and has not been studied in combination with basal insulin. Trulicity has not been studied in patients with severe gastrointestinal disease, including severe gastroparesis, and is not for patients with pre-existing severe gastrointestinal disease.

Lilly plans to make Trulicity 0.75 mg and 1.5 mg single-dose pens available for adults in the United States later this year. This marks the first approval for Trulicity anywhere in the world. It has also been submitted to the European Medicines Agency and other regulatory bodies.

"We are delighted with the approval of Trulicity. Lilly now has treatment options in several classes of diabetes medications: orals, GLPs and insulin," said Enrique Conterno, president, Lilly Diabetes. "Trulicity will help grow the GLP-1 receptor agonist class as a new choice for adults with type 2 diabetes."

The labeling for Trulicity contains a Boxed Warning regarding increased risk for thyroid C-cell tumors based on studies in rats. In rats, dulaglutide caused a dose-related and treatment-duration-dependent increase in the incidence of thyroid C-cell tumors (adenomas and carcinomas) after lifetime exposure. It is unknown whether Trulicity causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as human relevance could not be determined from clinical or nonclinical studies. Trulicity is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Routine serum calcitonin or thyroid ultrasound monitoring is of uncertain value in patients treated with Trulicity. Patients should be counseled regarding the risk factors and symptoms of thyroid tumors. See the Important Safety Information at the end of this press release, Prescribing Information and Medication Guide.

The biologics license application to the FDA was based on a number of studies of Trulicity used alone or in combination with commonly prescribed diabetes medications, including metformin, pioglitazone, glimepiride and insulin lispro. These studies included five large Phase 3 clinical trials from the Assessment of Weekly AdministRation of LY2189265 in Diabetes (AWARD) clinical development program. The efficacy of Trulicity was compared to four commonly used type 2 diabetes medicines: metformin, Januvia®, Byetta® and Lantus®.

Trulicity comes in a single-dose pen that does not require mixing, measuring or needle attachment. Trulicity is administered once a week, any time of day, independent of meals, and should be injected subcutaneously in the abdomen, thigh or upper arm. The recommended starting dose is 0.75 mg, which can be increased to 1.5 mg dose for patients who need additional blood sugar control.

"Type 2 diabetes is a progressive disease, and many patients have not reached their treatment goals," said Dr. David Kendall, vice president, medical affairs, Lilly Diabetes. "Trulicity is a new, non-insulin, injectable option that was designed with the patient in mind. It will be available in a once-weekly pen and does not require mixing, measuring nor needle handling."

Diabetes remains one of society's most prevalent diseases. More than 380 million people around the world have diabetes.1 In the U.S., the disease affects more than 29 million people.2 Type 2 diabetes is the most common, and the number of people with the disease is quickly growing.1

About Trulicity
Trulicity is a once-weekly, glucagon-like peptide-1 (GLP-1) receptor agonist injectable prescription medicine indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. Trulicity is not insulin. It acts like GLP-1, a natural hormone, helping the body release its own insulin when patients eat. 

Trulicity comes in a pen that does not require the patient to mix, measure or handle the needle. It can be taken any time of day, with or without meals, and should be injected subcutaneously in the abdomen, thigh or upper arm.

Indication and Limitations of Use for Trulicity
Trulicity is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.

Trulicity is not recommended as first-line therapy for patients inadequately controlled on diet and exercise. It has not been studied in patients with a history of pancreatitis, and other antidiabetic therapies should be considered for patients with a history of pancreatitis. Trulicity is not for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis. Trulicity is not a substitute for insulin and has not been studied in combination with basal insulin. Trulicity has not been studied in patients with severe gastrointestinal disease, including severe gastroparesis, and is not for patients with pre-existing severe gastrointestinal disease.

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