加拿大批准对4岁及以上年龄的Vamorolone,即首次新的Duchenne肌肉萎缩症治疗。 Canada approves vamorolone, first new Duchenne muscular dystrophy treatment, for ages 4 and up.

加拿大卫生部已核准AGAMEREE(vamorolone)治疗4岁及4岁以上的病人的杜尚尼亚肌肉萎缩症,这是加拿大为治疗这一疾病而核准的第一种疗法。 Health Canada has approved AGAMREE® (vamorolone) for treating Duchenne muscular dystrophy in patients aged 4 and older, the first therapy approved for the condition in Canada. 由Santhera制药公司开发的Vamorolone是一种分离性抗炎剂,旨在为小于其副作用,特别是对生长和骨骼健康的影响较小的园艺类固醇提供惠益。 Developed by Santhera Pharmaceuticals, vamorolone is a dissociative anti-inflammatory agent designed to provide benefits of corticosteroids with fewer side effects, particularly on growth and bone health. 经优先审查批准后,在VISION-DMD试验中,该试验显示安全和功效有所改善,增加了站立时间与安慰剂相比。 Approved following a Priority Review, it showed improved safety and efficacy in the VISION-DMD trial, enhancing time to stand versus placebo. 在加拿大,这种药物现在由Kye制药公司拥有的专属商业权利提供,Santhera公司获得特许使用费。 The drug is now available in Canada under exclusive commercial rights held by Kye Pharmaceuticals, with Santhera receiving royalties. 它仍在加强安全监测,并敦促保健提供者报告不良反应。 It remains under enhanced monitoring for safety, and healthcare providers are urged to report adverse reactions.