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欧洲药品管理局CHMP建议批准7种药物上市和2种药物扩展适应症

2019-11-18 不详 MedSci原创

欧洲药品管理局的人类用药产品委员会(CHMP)在11月的会议上,建议批准7种药物以及2种药物的扩展。

欧洲药品管理局的人类用药产品委员会(CHMP)在11月的会议上,建议批准7种药物以及2种药物的扩展。

7种建议批准的药物:

Isturisa(osilodrostat)被建议批准用于治疗成人内源性库欣氏综合症。Recordati最近从诺华获得了该皮质醇合成抑制剂的使用权。

Mayzent(siponimod)被建议批准用于治疗患有继发性进行性多发性硬化症的成年人。诺华的选择性1-磷酸鞘氨醇受体调节剂今年年初获得了FDA的批准。

Polivy(polatuzumab vedotin)被建议批准联合苯达莫司汀和MabThera(rituximab)用于治疗患有复发或难治性弥漫性大B细胞淋巴瘤的成年人,这些成年人不适合进行造血干细胞移植。罗氏针对CD79b的抗体-药物偶联物已于6月在美国获得加速批准。

Sunosi(solriamfetol)被建议批准用于治疗发作性睡病和阻塞性睡眠呼吸暂停患者的过度嗜睡。Jazz Pharmaceuticals的双作用多巴胺和去甲肾上腺素再摄取抑制剂在三月获得了 FDA的批准。

Tavlesse(fostamatinib)被建议批准用于治疗对其他治疗无效的慢性免疫性血小板减少症成年患者。去年,Rigel Pharmaceuticals的 SYK抑制剂在美国获得批准,以Tavalisse的形式出售,而 Grifols将在欧洲将该药物商业化。

Mylan针对赛诺菲和BMS的DuoPLavin(氯吡格雷/乙酰水杨酸)仿制药,被建议批准用于动脉粥样硬化血栓形成事件的二级预防

Accord Healthcare针对诺华Exjade(deferasirox)的仿制药,被建议批准用于治疗β地中海贫血和其他贫血患者因输血引起的慢性铁超负荷。

2种药物建议批准扩展适应症:

罗氏(Roche)抗体偶联药物Kadcyla(trasruzumab Emtansine)被建议批准用于在新辅助紫杉烷类药物和HER2靶向治疗后,在乳腺/淋巴结中有残留浸润性病灶的HER2阳性早期乳腺癌的成年人的辅助治疗。

Celgene的Revlimid(来那度胺)与MabThera(利妥昔单抗)合用,被建议批准用于治疗先前治疗过的滤泡性淋巴瘤的成人患者。

原始出处:


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    2019-11-20 医生2394
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欧洲药品管理局(EMA)已接受Prestige BioPharma公司的曲妥珠单抗生物仿制药Tuznue(HD201)的营销授权申请(MAA)。

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上星期六,欧洲药品管理局EMA工作人员下降了欧盟成员国的28面旗帜,并向伦敦办事处告别,迁往荷兰。搬迁的下一阶段应在几周内完成,当时EMA工作人员从3月1日起开始搬进位于阿姆斯特丹的Spark大楼。

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