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wachina

至尊木虫 (知名作家)

[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
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天使009

新虫 (小有名气)


小木虫: 金币+0.5, 给个红包,谢谢回帖
恒瑞今年开始I期临床,要断腕不算太晚。哎,可惜了。
8楼2013-12-31 09:35:56
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jinshanshi88

木虫 (著名写手)


小木虫: 金币+0.5, 给个红包,谢谢回帖
恒瑞这下悲剧了!
还不如壮士断腕,否则越走越远
2楼2013-12-30 12:41:43
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guri

铁虫 (初入文坛)


小木虫: 金币+0.5, 给个红包,谢谢回帖
呋格列泛只是恒瑞管线中的一个临床化合物,应该可以割舍掉。倒是整个糖尿病领域就没看到真正好的新靶点,这是非常值得忧虑的。。。
3楼2013-12-30 13:06:43
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wph75623

铜虫 (小有名气)


小木虫: 金币+0.5, 给个红包,谢谢回帖
糖尿病如何治疗,病因如何,仍是未知的,这样的代谢紊乱疾病其实是机体内脏功能失调的表现,目前西药都是治标不治本,研究能治愈该疾病的药物才是终极目标,现在的药都是在抄个靶点的概念,对患者难有实在的益处
4楼2013-12-30 16:49:55
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