5月31日消息 - 环球医学据悉，欧洲药品管理局（EMA）的顾问上周为用于治疗2型糖尿病的含有二肽基肽酶4（DPP-4）抑制剂利拉利汀与盐酸二甲双胍的复方药片（Jentadueto，勃林格殷格翰公司/礼来公司）的获批铺平了道路。

EMA人用医药产品委员会（CHMP）针对应用该药与饮食和运动相结合，来改善那些在最大耐受剂量的二甲双胍单用或利拉利汀和二甲双胍联合治疗下血糖仍控制不足的2型糖尿病成人患者的升胰岛素控制发表了“积极意见”。CHMP还指出，该药可与磺脲类药物联合应用（即三联综合疗法）来辅助饮食和运动疗法，用于在最大耐受剂量的二甲双胍和磺脲类药治疗下血糖控制不足的成年患者。

CHMP的积极意见是欧盟委员会泛欧批准的先决条件，欧盟委员会将在CHMP发布积极意见后67天给予正式批准。

Jentadueto的用法为每日两次，每次一片，该药将有两种剂量在欧盟上市：2.5mg利拉利汀/850mg二甲双胍和2.5mg利拉利汀/1000mg二甲双胍。该药已于2012年1月获得美国FDA批准。（环球医学）

原文：

EU Okays Combination Type 2 Diabetes Pill

Advisors for the European Medicines Agency (EMA) last week paved the way for approval of a combination pill containing the dipeptidyl peptidase-4 (DPP-4) inhibitor linagliptin and metformin hydrochloride (Jentadueto, Boehringer Ingelheim/Eli Lilly) for type 2 diabetes [1].

The EMA's Committee for Medicinal Products for Human Use (CHMP) issued a "positive opinion" for the product for use alongside diet and exercise to improve glycemic control in adults with type 2 diabetes who are inadequately controlled on their maximal tolerated dose of metformin alone or those already being treated with the combination of linagliptin and metformin [2]. It is also indicated in combination with a sulfonylurea (ie, triple combination therapy) as an adjunct to diet and exercise in adult patients inadequately controlled on their maximal tolerated dose of metformin and a sulfonylurea.

A positive opinion from the CHMP is a prerequisite to pan-EU approval by the European Commission, which has 67 days from the date of the opinion to grant approval.

Jentadueto is designed to be taken as a single table twice daily and would be available in two strengths in the EU: 2.5-mg linagliptin/850-mg metformin and 2.5 mg/1000 mg. The combination product was approved by the US FDA in January.
 

相关链接：http://www.medscape.com/viewarticle/764700 

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