此前，Trulicity已于今年9月获得FDA批准，标志着该药的首个监管批准。而此次Trulicity在欧盟获批，也标志着礼来全球糖尿病项目的另一个关键的里程碑。目前，礼来也正在等待其他几个市场的监管批准。
糖尿病新药研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，该市场的竞争异常激烈。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。目前市场已“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。
而Trulicity一举拿下美欧2大主要市场，也使得四面楚歌的礼来终于赢得一场硬仗。另外，在头对头临床研究中，Trulicity的表现也没让人失望，不仅击败了阿斯利康Byetta和默沙东Januvia+二甲双胍疗法，同时疗效媲美诺和诺德Victoza。Victoza年销20亿美元，在GLP-1市场傲视群雄。Victoza每日注射一次，而Trulicity每周注射一次，用药方面具有很大的优势，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。这将成为礼来营销Trulicity时的卖点，该药也将成为Victoza更方便的替代者。另外，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。业界预测，Trulicity将成为糖尿病市场的重磅炸弹。
关于Trulicity的前景，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。
具体而言，欧盟委员会（EC）已批准Trulicity：（1）联合其他降糖药（包括胰岛素），用于这些药物联合饮食和运动未实现充分血糖控制的2型糖尿病成人患者；（2）作为单药疗法，用于饮食和运动未能充分控制血糖水平且因不耐受或禁忌症而不适用二甲双胍的2型糖尿病成人患者。
Trulicity 1.5mg剂量（每周注射一次）推荐用于Trulicity及其他降糖药的联合疗法；Trulicity 0.75mg剂量（每周注射一次）推荐用作单药疗法，同时可用作某些脆弱群体（包括75岁及以上群体）的起始治疗剂量。
英文原文：European Commission Approves Trulicity (dulaglutide) Solution for Injection, Lilly's Once-Weekly, Ready-to-Use Type 2 Diabetes Treatment
- Trulicity, a glucagon-like peptide-1 (GLP-1) receptor agonist, is the only non-insulin, injectable diabetes treatment available in a pen with a no-see, no-handle needle
INDIANAPOLIS, Nov. 25, 2014 /PRNewswire/ -- Eli Lilly and Company announced today that the European Commission granted marketing authorisation for Trulicity? (dulaglutide) solution for injection. Trulicity, a GLP-1 receptor agonist, is a once-weekly, injectable solution designed to improve glycaemic control in adults with type 2 diabetes. The medicine comes in a ready-to-use pen with a pre-attached, hidden needle. Trulicity received a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) on 25 September 2014.
"Trulicity's approval in the European unio represents another significant milestone in Lilly's global diabetes programme," said Jeremy Morgan, vice president, Lilly Diabetes International. "Across the region, diabetes remains a burden on the health system, and we look forward to helping even more patients with type 2 diabetes reach their treatment goals."
Trulicity is indicated to improve glycaemic control in adults with type 2 diabetes:
in combination with other glucose-lowering medicines, including insulin, when these, together with diet and exercise, do not provide adequate glycaemic control; and as
monotherapy, when diet and exercise alone do not provide adequate glycaemic control in patients for whom the use of metformin is considered inappropriate due to intolerance or contraindications.
Trulicity 1.5 mg once weekly is recommended for those taking Trulicity in combination with other diabetes treatments. Trulicity 0.75 mg once weekly is the recommended dose for patients taking it as monotherapy and can be considered as a starting dose (in combination with other diabetes treatments) for certain vulnerable populations, including patients aged 75 years and older.
The marketing authorisation is based, in part, on results from a number of studies, including six large Phase 3 clinical trials. In the first five trials, Trulicity 1.5 mg was superior to placebo and four commonly used type 2 diabetes medicines in reducing average blood sugar levels (HbA1c). Trulicity 0.75 mg provided similar HbA1c reductions in one of the trials, and demonstrated superiority in the other four. In the sixth trial, Trulicity 1.5 mg showed similar HbA1c reductions to the highest approved dose of a commonly used once-daily GLP-1 receptor agonist.
The most frequently reported adverse events were gastrointestinal-related and, when used in combination with mealtime insulin or metformin plus glimepiride, documented symptomatic hypoglycaemia (low blood sugar). These adverse events are consistent with those seen with other GLP -1 receptor agonists.
Trulicity received approval from the U.S. Food and Drug Administration on 18 Sept. 2014, and has several other pending regulatory applications. Trulicity will be available to patients in Europe in 2015.
about Diabetes
An estimated 387 million people worldwide have type 1 and type 2 diabetes. Type 2 diabetes is the most common type, accounting for an estimated 90 to 95 percent of all diabetes cases. Diabetes is a chronic disease that occurs when the body either does not properly produce, or use, the hormone insulin.[1]
about Trulicity
Trulicity is a once-weekly, glucagon-like peptide-1 (GLP-1) receptor agonist injectable prescription medicine. 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.
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