尽管美国批准了,但欧盟仍推迟批准Roche's Duchenne肌肉萎缩基因疗法。 EU delays approval of Roche's Duchenne muscular dystrophy gene therapy, despite U.S. approval.

欧洲药品署对Roche为患有杜尚肌肉萎缩症的儿童提供的Elevidys基因疗法发表了负面意见,推迟了在欧盟的核准。 The European Medicines Agency has issued a negative opinion on Roche's gene therapy Elevidys for children with Duchenne muscular dystrophy, delaying its approval in the EU. 尽管如此,Roche仍计划继续与EMA合作,以寻求可能的核准。 Despite this, Roche plans to continue working with the EMA to seek potential approval. Elevidis是针对该疾病根本原因的首例疗法,表明病人的肌肉健康和功能有显著改善。 Elevidys is the first therapy to target the disease's underlying cause, showing significant improvements in patients' muscle health and function. 2023年6月美国食品药品管理局批准了治疗。 The therapy had been approved by the FDA in the US in June 2023.