强生糖尿病新药VOKANAMET获欧盟批准

关键词:2型糖尿病,强生,VOKANAMET,canagliflozin,二甲双胍,SGLT2抑制剂

2014年4月26日讯 /生物谷BIOON/ --强生(JNJ)4月25日宣布,糖尿病新药VOKANAMET获欧盟委员会(EC)批准,用于2型糖尿病成人患者的治疗,以改善血糖控制。VOKANAMET的获批,是基于在横跨不同糖尿病群体中开展的全面全球III期项目的数据。

VOKANAMET是由固定剂量canagliflozin和速释二甲双胍(metformin)组成的单一片剂,每日2次,该药适用于:(1)最大耐受剂量二甲双胍仍不能充分控制血糖水平的患者;(2)最大耐受剂量二甲双胍联合其他降糖药(包括胰岛素)仍不能充分控制血糖水平的患者;(3)正在接受canagliflozin和二甲双胍组合疗法的患者。

Canagliflozin(商品名INVOKANA)是日服一次的口服糖尿病药物,已分别于2013年3月和11月获FDA和欧盟批准上市,该药属于选择性纳葡萄糖共转运体2(SGLT2)抑制剂的一类新药,通过阻断肾脏对血糖的重吸收及增加尿液中血糖的排泄,来降低机体血糖水平。

与非糖尿病人群相比,2型糖尿病患者的肾脏能够重吸收大量的葡萄糖进入血液,这可能会推高血糖水平。

二甲双胍则是2型糖尿病治疗的一线药物,可单独或与其他药物(包括胰岛素)联合用药。在2型糖尿病患者中,肝脏产生过量的葡萄糖(glucose),从而提高血糖水平。二甲双胍可通过降低肝脏产生葡萄糖的量、增加肌肉对葡萄糖的敏感性、延缓肠道的葡萄糖吸收,降低机体的血糖水平。(生物谷Bioon.com)

英文原文:VOKANAMET® (canagliflozin and immediate release metformin hydrochloride fixed dose combination) approved in the European Union for treatment of adults with type 2 diabetes

BEERSE, April 25 2014 – Janssen-Cilag International NV (Janssen) announced today that the European Commission (EC) has approved VOKANAMET® (a fixed-dose therapy combining canagliflozin and immediate release metformin hydrochloride in a single tablet) in the European Union, for the treatment of adults with type 2 diabetes mellitus to improve glycaemic control.[1] Canagliflozin as a single agent was approved as INVOKANA® in the European Union in November 2013.[2]

This EC decision follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), recommending the approval of canagliflozin and immediate release metformin hydrochloride fixed dose combination therapy, in February 2014. The combination therapy, which is taken as a single pill twice daily, is indicated in adults aged 18 years and older with type 2 diabetes mellitus to improve glycaemic control in:

—patients not adequately controlled on their maximally tolerated doses of metformin alone;[1]

—patients on their maximally tolerated doses of metformin along with other glucose lowering medicinal products including insulin, when these do not provide adequate glycaemic control;[1]

—patients already being treated with the combination of canagliflozin and metformin as separate tablets;[1]

Professor Guntram Schernthaner, Department of Medicine I, Rudolfstiftung Hospital, Austria comments, “The approval of VOKANAMET® in the European Union is very welcome news for the growing number of people with type 2 diabetes in this region. Many patients struggle to achieve and maintain long-term glycaemic control, and the introduction of VOKANAMET® provides added convenience to diabetes management, particularly to those patients who may benefit from two diabetes medications in one tablet.”

Commenting on the approval, Jane Griffiths, Company Group Chairman, Janssen Europe, Middle East, and Africa said, “We are delighted that the European Commission has approved VOKANAMET® for use in the European Union, recognising the value and the convenience that this combined treatment option provides for patients. This approval further reinforces Janssen’s ongoing commitment to provide new therapeutic options that help to address unmet needs in the treatment of type 2 diabetes.”

The EC approval of this fixed-dose therapy combining canagliflozin and immediate release metformin hydrochloride in a single tablet taken twice daily was based on significant portions of the comprehensive global Phase 3 clinical development programme for canagliflozin single agent, including the studies with co-administration of metformin and canagliflozin as individual tablets.

The Phase 3 programme evaluated the safety and efficacy of canagliflozin across the spectrum of type 2 diabetes and included placebo and active comparator controlled studies. Three studies have compared canagliflozin to current standard treatments,[3-5] two of which compared canagliflozin to sitagliptin as dual therapy with metformin and the other as triple therapy with metformin and sulphonylurea[3,4]. In addition there is a study comparing canagliflozin to glimepiride as dual therapy with metformin.[5] The Phase 3 programme also included two large studies in special populations:[6-7] patients over age 55 with type 2 diabetes[6] and patients with type 2 diabetes who were considered to be at high risk for cardiovascular disease.[7]

Single agent canagliflozin (INVOKANA®) was approved in the US in March 2013, and in the European Union, as well as Norway, Liechtenstein and Iceland in November 2013.[2]

Canagliflozin is a member of a new class of drugs known as sodium glucose co-transporter 2 (SGLT2) inhibitors. SGLT2 inhibitors contribute to controlling blood glucose levels via the kidney. As glucose is filtered from the blood into the kidneys, it is reabsorbed back into the bloodstream. An important transport carrier in the renal proximal tubule responsible for this reabsorption is called sodium glucose co-transporter 2 (SGLT2). Canagliflozin selectively inhibits SGLT2, and, as a result, promotes the loss of glucose via the urine, lowering blood glucose levels in adults with type 2 diabetes. This mechanism of action is independent of insulin.[2]

Metformin is a first-line pharmacotherapy that can be used alone or with other medications, including insulin, to treat type 2 diabetes. In people with type 2 diabetes, the liver overproduces glucose, which increases blood glucose levels. Metformin lowers blood glucose levels by decreasing the amount of glucose made by the liver, increasing insulin sensitivity in the muscle and delaying intestinal glucose absorption.[8]

Janssen and its affiliates have rights to canagliflozin through a license agreement with Mitsubishi Tanabe Pharma Corporation. Janssen and its affiliates have marketing rights in North America, South America, Europe, the Middle East, Africa, Australia, New Zealand and parts of Asia.

(责任编辑:lishuheng)

小编提示:87%用户都在生物谷APP上阅读,扫描立刻下载!

您还可以这样阅读

微信扫一扫,体验新式阅读

打开微信扫描二维码

生物谷微信账号:bioonnews

我们提供多种阅读途径供您选择,随时随地掌握医药生物领域最新资讯。

生物谷微信二维码

    相关资料

    欢迎行业评论、发现、小道消息、官方爆料、采访约稿

    我要投稿   下载App支持编辑