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Secukinumab: First Global Approval

机译:Secukinumab:首次全球批准

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摘要

Secukinumab (Cosentyx (TM)) is a fully human monoclonal antibody against interleukin-17A, formulated for intravenous and subcutaneous administration. It received its first global approval in Japan on 26 December 2014 for the treatment of psoriasis and psoriatic arthritis in adults who are not adequately responding to systemic therapies (except for biologic agents). In the USA and the EU, secukinumab was approved in early 2015 for the treatment of patients with moderate-to-severe plaque psoriasis. Secukinumab is also being investigated in patients with ankylosing spondylitis and rheumatoid arthritis. This article summarizes the milestones in the development of secukinumab leading to its first approval for the treatment of adult patients with psoriasis and psoriatic arthritis.
机译:Secukinumab(Cosentyx(TM))是针对白介素17A的完全人类单克隆抗体,配制用于静脉内和皮下给药。它于2014年12月26日在日本获得了全球首个批准,用于治疗对全身疗法反应不足的成人(生物制剂除外)的牛皮癣和牛皮癣关节炎。在美国和欧盟,苏金单抗于2015年初获准用于治疗中度至重度斑块状牛皮癣的患者。 Secukinumab也正在强直性脊柱炎和类风湿关节炎患者中进行研究。本文概述了secukinumab的发展过程中的里程碑,这使它首次被批准用于治疗成人牛皮癣和牛皮癣关节炎患者。

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