罗氏新一代抗体疗法获积极监管决定

金融界07-01

日前，罗氏(Roche/RHHBY.US)宣布，欧洲药品管理局(EMA)的人用药品委员会(CHMP)已对其新一代C5循环抗体Piasky(crovalimab，可伐利单抗)用以治疗阵发性睡眠性血红蛋白尿症(PNH)采纳了积极意见。CHMP建议PiaSky适用于未曾或已接受过C5抑制剂治疗的成年和青少年(12岁及以上且体重不低于40公斤)。如果获批，PiaSky将成为欧盟首个每月一次的皮下(SC)...

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