Eperzan(R) (Albiglutid)
|
Name |
Eperzan |
|
INN or common name |
albiglutide
|
|
Therapeutic area |
Diabetes Mellitus, Type 2 |
|
Active substance |
albiglutide
|
|
Date opinion adopted |
23/01/2014 |
|
Company name |
GlaxoSmithKline Trading Services
|
|
Status |
Positive |
|
Application type |
Initial authorisation |
http://www.ema.europa.eu/docs/en_GB/document_library/Summary_of_opinion_-_Initial_authorisation/human/002735/WC500159960.pdf
欧盟委员会已授予葛兰素史克公司糖尿病治疗新药Eperzan（Albiglutide）上市许可，该药将与礼来公司的Bydureon（Exenatide，艾塞那肽）狭路相逢。
Eperzan与Bydureon这两种GLP-1受体激动剂都是相对较新类型的每周注射一次的缓释制剂，旨在帮助使用口服药、短效和长效胰岛素产品失败的患者降低血糖水平（HbA 1c）。
Eperzan适用于依靠节制饮食和运动不能控制血糖水平而又不能使用二甲双胍的II型糖尿病成人患者作为单一治疗药。
它也可被用作与其它降糖药如基础胰岛素联合治疗的附加药物。
葛兰素史克还在等待美国FDA的最终决定，Eperzan被延期三个月审批，预期在4月15日得出结论。
2013年1月和3月，葛兰素史克先后向FDA和欧洲药品局提出申请，计划在几年第三季度在欧盟几个国家上市，随后扩大市场。
欧盟的这一决定基于一项名为Harmony的计划结果，......
Forthcoming Submission: albiglutide (Eperzan)
Indication: for the treatment of type 2 diabetes mellitus (T2DM) in adults to improve glycaemic control as: • Monotherapy: When diet and exercise alone do not provide adequate glycaemic control in patients for whom use of metformin is considered inappropriate due to contraindications or intolerance. • Add-on combination therapy: In combination with other glucose-lowering medicinal products including basal insulin, when these, together with diet and exercise, do not provide adequate glycaemic control.
Drug Details
|
Drug Name: |
albiglutide (Eperzan) |
|
Drug Manufacturer: |
GlaxoSmithKline UK Ltd |
|
BNF Category: |
6. Endocrine system |
|
Sub Category: |
6.1 Drugs used in diabetes |
|
Submission type: |
Full submission |
|
SMC Meeting Date: |
To be confirmed |
|
Advice Due: |
To be confirmed |
