AstraZeneca: FDA Grants Orphan Drug Designation To Tezepelumab For Eosinophilic Esophagitis

阿斯利康:FDA授予替西培单抗治疗嗜酸性食管炎的孤儿药称号

2021-10-16 04:30:11 RTTNews

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British drug major AstraZeneca Plc. (AZN,AZN.L) announced Friday that the U.S. Food and Drug Administration or FDA has granted Orphan Drug Designation to Tezepelumab for the treatment of eosinophilic esophagitis or EoE. Tezepelumab is being developed by AstraZeneca in collaboration with Amgen. It is under Priority Review for patients with asthma in the US. The FDA grants ODD status to medicines and potential new medicines intended for the treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the US. EoE is a rare, chronic, inflammatory disease which involves a range of inflammatory cells that contribute to debilitating symptoms for patients, including severe pain and difficulty swallowing food. There are currently no approved treatments for eosinophilic esophagitis in the US. The companies expect a decision on tezepelumab's Priority Review in patients with asthma in the US in the first quarter of 2022. Tezepelumab is also under regulatory review for asthma in the EU and Japan. For comments and feedback contact: editorial@rttnews.com
英国制药巨头阿斯利康有限公司。(AZN,AZN.L)周五宣布,美国食品药品监督管理局或FDA已批准替泽普鲁单抗为孤儿药,用于治疗嗜酸性食管炎或EOE。 阿斯利康正与安进公司合作开发替泽普鲁单抗。它正在美国哮喘患者的优先审查中。 美国食品和药物管理局授予用于治疗、诊断或预防罕见疾病或疾病的药物和潜在新药奇数地位,这些疾病影响美国不到20万人。 EoE是一种罕见的慢性炎症性疾病,涉及一系列炎症细胞,导致患者虚弱的症状,包括严重疼痛和吞咽食物困难。目前在美国没有批准的治疗嗜酸细胞性食管炎的方法。 这些公司预计,2022年第一季度将决定泰泽普鲁单抗在美国哮喘患者中的优先审查。Tezepelumab也在欧盟和日本接受哮喘监管审查。 如需评论和反馈,请联系:editorial@rttnews.com

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