24小时热门版块排行榜

>论坛更新日志 (999)
>虫友互识 (31)
>导师招生 (20)
>论文投稿 (20)
>考研 (18)
>找工作 (17)
>教师之家 (16)
>基金申请 (15)
>硕博家园 (15)
>考博 (15)
>公派出国 (15)
>博后之家 (13)
>休闲灌水 (12)
>论文道贺祈福 (11)
>有机交流 (10)
>文献求助 (8)

返回列表

当前只显示满足指定条件的回帖，点击这里查看本话题的所有回帖

wachina

至尊木虫 (知名作家)

应助: 228 (大学生)
贵宾: 0.03
金币: 15996.8
散金: 2
红花: 13
帖子: 5306
在线: 683.4小时
虫号: 770872
注册: 2009-05-15
性别: GG
专业: 合成药物化学

[交流] 武田fasiglifam (TAK-875)宣告失败，恒瑞呋格列泛齿亡唇寒已有16人参与

Takeda terminates development activities for fasiglifam (TAK-875)

Takeda Pharmaceutical Company Limited (Takeda) announced that it has decided voluntarily to terminate the development activities for fasiglifam (TAK-875), an investigational treatment for type 2 diabetes, due to concerns about liver safety.

Patient safety is Takeda's highest priority. The company has worked with three independent panels of experts to provide for the safety of trial participants and ensure independent safety oversight for the clinical trials throughout the duration of the fasiglifam (TAK-875) Phase 3 development program.

The expert panels include the independent Data Monitoring Committee (DMC), a committee that oversees the fasiglifam global clinical development program, reviews the unblinded clinical data from program trials and provides continual safety oversight of trial subjects and recommendations. The DMC is comprised of clinical experts in endocrinology, cardiology and hepatology as well as a statistician. The independent Liver Safety Evaluation Committee (LSEC) is comprised of five hepatologists with expertise in drug-induced liver injury. While remaining blinded to treatment information, the LSEC regularly evaluates data on liver enzymes elevations and adjudicates cases that impacted the liver. In addition, an independent Executive Committee (EC) provides additional oversight for the fasiglifam (TAK-875) cardiovascular outcomes trial.

After careful consideration of the data emerging from all the clinical trials and in consultation with these panels, the company has reached the conclusion that, on balance, the benefits of treating patients with fasiglifam (TAK-875) do not outweigh the potential risks. For this reason, Takeda has decided voluntarily to terminate the development activities for fasiglifam.
作为慢性疾病：糖尿病的治疗，肝毒性太致命了，难怪武田挥泪斩马谡。值得一提的是，恒瑞也向CFDA申报了GPR-40激动剂呋格列泛，现在心里估计也是拔凉拔凉的

回复此楼