2月21日，强生（JNJ）旗下杨森（Janssen）宣布，糖尿病新药VOKANAMET获得了欧洲药品管理局（EMA）人用医药产品委员会（CHMP）的积极意见。CHMP建议批准VOKANAMET用于治疗2型糖尿病患者。
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。同时，在2型糖尿病患者中，肝脏也会产生过量的葡萄糖（glucose）提高血糖水平。基于以上认识，VOKANAMET是由固定剂量canagliflozin和速释二甲双胍（metformin）组成的单一片剂。
Canagliflozin（商品名INVOKANA）是日服1次的口服2型糖尿病药物，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。Canagliflozin是强生公司最有前途的药物候选者之一。该公司旗下杨森部门拥有该药在北美、南美、欧洲、中东、非洲、澳大利亚、新西兰及一些亚洲国家的销售权。
二甲双胍作为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。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.
New Drugs Online Report for canagliflozin + metformin IR
Information
Generic Name: canagliflozin + metformin IR
Trade Name: Vokanamet (EU), Invokamet (US)
Entry Type: New formulation
Developmental Status
UK: Approved (Licensed)
EU: Approved (Licensed)
US: Approved (Licensed)
UK launch Plans: Available only to registered users
Actual UK launch date:
Comments
Aug 14: Approved in the US [10]
11/08/2014 22:09:57
Apr 14: The European Commission has approved VOKANAMET® (a fixed-dose therapy combining canagliflozin and immediate release metformin hydrochloride) in the EU, for the treatment of adults with type 2 diabetes mellitus to improve glycaemic control [8].
19/06/2014 14:51:02
Feb 14: Johnson & Johnson submit a response to the FDA [9].
19/06/2014 14:50:50
Feb 14: Positive opinion granted in the EU for the treatment type 2 diabetes mellitus [7]
22/02/2014 18:15:48
Dec 13: The FDA has issued a complete response letter for a fixed-dose combination of canagliflozin and immediate-release metformin to treat adults with T2DM. The letter asks for additional information to support the comparability of the twice-daily dosing regimen of canagliflozin as part of the canagliflozin and metformin combination and the once-daily dosing of canagliflozin as a single agent. Janssen believes it can supply this information based on available clinical data [6].
13/12/2013 13:41:35
Mar 13: Filed in EU Mar 13 [5]
26/03/2013 14:44:39
Dec 12: New Drug Application submitted to US FDA [4]
13/12/2012 12:05:23
PIII in EU & US [1].
06/12/2011 16:02:22
Trial or other data
Apr 12: No further update.
19/04/2012 14:18:16
Four PI studies in healthy volunteers started in 4Q 11: NCT01454622 is eva luating the bioequivalence of canagliflozin/metformin immediate-release vs. the individual components in 64 US subjects from the US; NCT01459094 is an open-label crossover study comparing the bioavailability of canagliflozin/metformin IR when given with or without food in 24 US volunteers; NCT01463774 is comparing fixed-dose canagliflozin/metformin to separate canagliflozin & metformin in 64 US subjects; NCT01463228 is assessing the bioequivalence of the fixed-dose combination vs. individual components in 64 US individuals [2].
07/12/2011 10:30:27
Evidence Based eva luations
EPAR http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/002656/WC500166672.pdf
References
Available only to registered users
Category
BNF Category: Other antidiabetics (06.01.02.03)
Pharmacology: Selective sodium glucose co-transporter type 2 (SGLT2) inhibitor plus biguanide, metformin
Epidemiology: Over 5% of men & 4% of women in England have diagnosed diabetes, & it has been estimated that 3.1% of men & 1.5% of women aged 35 and over have undiagnosed diabetes (85% type 2) [3].
Indication: Type 2 diabetes mellitus
Method(s) of Administration
Oral
Company Information
Name: Janssen-Cilag
US Name: Scios
NICE Information
In timetable: No
When:
PBR Likely Healthcare Resource Group included.
Service
Implications Available only to registered users
Prescribing
Outlook: Available only to registered users
