2015年3月14日讯/生物谷BIOON/--近日，美国FDA考虑重新审核百时美施贵宝的丙肝药daclatasvir与吉利德Sovaldi (sofosbuvir)联合用药治疗3型丙肝。
FDA表示将会在未来六个月期限内审核，而基于的数据就是之前ALLY-3的3期临床试验。
新的临床试验结果非常乐观，此前未接受过治疗的患者中，90%用药后能产生12周持续病毒学应答，而有过治疗史的患者，这个数字也达到了86%。
施贵宝表示，在无肝硬化的3型丙肝患者中，治疗应答率达到了惊人的96%。并且患者对治疗的耐受性良好，在整个临床试验中没有发生死亡以及与治疗相关的严重副反应，也没有患者因为副反应而终止治疗。
尽管目前治疗丙肝的手段已经有了长足的进步，但仍有许多患者的治疗需求无法得到满足。目前在美国，9%—12%的3型丙肝患者的治疗选择仍旧非常局限，需要新药满足这部分患者的需求。
百时美施贵宝的daclatasvir也算是好事多磨，从去年11月份被FDA要求推迟上市，到新的临床试验表现优异、重新获得FDA的青睐，可谓是历尽艰辛，未来是否能顺利获批，可以拭目以待。
原文 FDA to re-review B-MS' hep C combo
US regulators have agreed to re-review Bristol-Myers Squibb’s application to market its investigational hepatitis C drug daclatasvir in combination with Gilead’s Sovaldi (sofosbuvir) for patients with genotype 3 forms of the disease.
The US Food and Drug Administration said it will review the submission - which now includes data from the Phase III ALLY-3 trial - within a six-month timeframe.
New clinical data show high cure rates for the daclatasvir/sofosbuvir combination， with sustained virologic response 12 weeks after treatment in 90% of treatment-na？ve and 86% of treatment-experienced genotype 3 HCV patients.
Response rates were higher - 96% - in non-cirrhotic genotype 3 patients， regardless of treatment history， the firm said， and also noted that， overall， the regimen was well-tolerated， with “no deaths， treatment-related serious adverse events， or discontinuations due to adverse events” in the trial.
B-MS says it is hoping to address a high unmet patient need that still exists despite recent hepatitis C treatment advances， given that around 9%-12% of HCV patients in the US have genotype 3 and limited treatment options.