近日，勃林格殷格翰-礼来糖尿病联盟近日在美国监管方面收获喜讯，双方合作研发的2型糖尿病复方新药Synjardy（empagliflozin/盐酸二甲双胍）获FDA批准，用于2型糖尿病（T2D）成人患者的治疗，该药于今年6月也获得了欧盟的批准。
Synjardy是勃林格-礼来糖尿病联盟在过去4年中获得FDA批准的第5款产品，也是获批的第3款包含empagliflozin（恩格列净）的产品，另外2款产品为Jardiance（empagliflozin）和Glyxambi（empagliflozin/linagliptin）。
Synjardy是由empagliflozin（恩格列净）和盐酸二甲双胍组成的复方单片，具有2种独特的降血糖机制。empagliflozin属于新兴的钠-葡萄糖协同转运蛋白-2（SGLT-2）抑制剂类降糖药，能够阻断肾脏中葡萄糖的再吸收作用，将过多的葡萄糖排泄到体外，达到降血糖疗效，而且该降糖效果不依赖于β细胞功能和胰岛素抵抗。盐酸二甲双胍则是一种常见的2型糖尿病初始治疗药物，可降低肝糖的产生，降低小肠对葡萄糖的吸收，并可通过增加外周组织对葡萄糖的摄取和利用而提高胰岛素的敏感性。
Synjardy适应症为结合饮食及运动，用于改善2型糖尿病成人患者的血糖控制，适用人群为：
（1）接受含empagliflozin或二甲双胍方案仍不能充分控制血糖水平的2型糖尿病患者；
（2）正在接受empagliflozin和二甲双胍联合治疗的2型糖尿病患者。
Synjardy不适用于1型糖尿病或糖尿病酮症酸中毒（血液或尿液中酮体升高）的治疗，该药的产品标签上含有一个警示框，提示该药的乳酸性酸中毒风险，这是一种严重的代谢性并发症，是由于Synjardy治疗期间可能出现的二甲双胍积累所致。
Synjardy的获批，是基于多个临床试验的强劲数据，这些试验调查了empagliflozin联合二甲双胍单独治疗或与其他降糖药（吡格列酮、磺脲类、DPP-4抑制剂、胰岛素）联合治疗时的疗效和安全性。

INGELHEIM, Germany & INDIANAPOLIS, US--(BUSINESS WIRE)--Synjardy has been granted marketing authorisation by the European Commission for the treatment of adults with type 2 diabetes (T2D) in the European Union (EU). Synjardy is a new single-pill combination therapy from the Boehringer Ingelheim and Eli Lilly and Company diabetes alliance.

Synjardy combines empagliflozin, a sodium glucose cotransporter 2 (SGLT2) inhibitor, and metformin hydrochloride (HCl), commonly prescribed for the treatment of T2D. Empagliflozin was approved in the EU in May 2014 and is available in many countries as an oral, once-daily tablet, marketed as Jardiance.

Synjardy is indicated for use alongside diet and exercise to improve blood glucose control in adults with T2D when they are:

Inadequately controlled on their maximally tolerated dose of metformin aloneInadequately controlled with metformin in combination with other glucose-lowering medicinal products, including insulinAlready being treated with the combination of empagliflozin and metformin as separate tablets
“A single medicine is often not sufficient for patients to maintain blood glucose control in the long term, resulting in the need for combinations of blood glucose-lowering drugs,” said Professor Klaus Dugi, Chief Medical Officer, Boehringer Ingelheim. “We are delighted to offer this single-pill combination of two agents with different mechanisms. Synjardy may help adults with T2D achieve their blood glucose targets with the added benefit of a convenient treatment regimen.”

The marketing authorisation follows the positive opinion from the Committee for Medicinal Products for Human Use of the European Medicines Agency in March 2015.

About the Phase III Clinical Trials

The marketing authorisation is based on the submission of robust clinical data from seven Phase III clinical trials eva luating the safety and efficacy of empagliflozin as add-on to metformin either alone or in combination with other blood glucose-lowering drugs (pioglitazone, sulphonylurea, DPP-4 inhibitors and insulin). More than 7,000 patients with T2D participated, of which over 4,700 were treated with empagliflozin as add-on to metformin.

The results showed that treatment with empagliflozin (10mg and 25mg) when added to metformin, with or without other blood glucose-lowering drugs, led to clinically relevant reductions in blood glucose, body weight and blood pressure compared to placebo as add-on to metformin.

The most common side effect reported by patients in the clinical trials was hypoglycaemia (low blood glucose) when empagliflozin and metformin were used in combination with insulin and/or sulphonylurea. In general, the adverse event profile of empagliflozin as add on to metformin was consistent with the known safety profile of the individual compounds empagliflozin and metformin.

The common side effects experienced with empagliflozin are urinary tract and genital infections, increased urination and itching. The common side effects experienced with metformin are gastrointestinal symptoms such as nausea, vomiting, diarrhoea, abdominal pain and loss of appetite as well as taste disturbance.

About empagliflozin/metformin hydrochloride (HCl)

Empagliflozin/metformin HCl should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis. For further information on contraindications, warnings and precautions for use please refer to the summary of product characteristics.

Empagliflozin/metformin HCl will be made available in the following twice-daily doses in the EU:

5mg empagliflozin plus 850mg or 1000mg metformin HCl12.5mg empagliflozin plus 850mg or 1000mg metformin HCl
Intended audiences

This press release is issued from Boehringer Ingelheim Corporate Headquarters in Ingelheim, Germany and is intended to provide information about our global business. Please be aware that information relating to the approval status and labels of approved products may vary from country to country, and a country-specific press release on this topic may have been issued in the countries where Boehringer Ingelheim and Eli Lilly and Company do business.

Please click on the link below for ‘Notes to Editors’ and ‘References’:

http://www.boehringer-ingelheim.com/news/news_releases/press_releases/2015/28_may_2015_diabetes.html