欧洲药品管理局 CHMP 建议批准百时美施贵宝的贫血药物 Reblozyl,用于治疗成人 MDS 输血依赖性贫血。 The European Medicines Agency's CHMP recommended approval for Bristol Myers Squibb's anemia drug Reblozyl for transfusion-dependent anemia in adults with MDS.
百时美施贵宝的贫血药物 Reblozyl(luspatercept)获得了欧洲药品管理局人用药品委员会 (CHMP) 的积极评价,该药物用于治疗因极低、低和中度贫血而导致的输血依赖性贫血成人患者。存在骨髓增生异常综合征(MDS)的风险。 Bristol Myers Squibb received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) for its anemia drug Reblozyl (luspatercept) as a treatment for adults with transfusion-dependent anemia due to very low, low, and intermediate-risk myelodysplastic syndromes (MDS). CHMP 的建议现在将由欧盟委员会审查,该委员会有权批准欧盟药品。 The CHMP's recommendation will now be reviewed by the European Commission, which has the authority to approve medicines for the European Union. 如果获得批准,这将是 Reblozyl 在欧盟的第四个授权适应症。 If approved, this would be the fourth authorized indication for Reblozyl in the EU.