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Ponesimod: First Approval

机译:PONESIMOD:首次批准

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摘要

Ponesimod (PONVORY (TM)) is an orally administered selective sphingosine-1-phosphate (S1P) receptor 1 (S1P(1)) agonist being developed by the Janssen Pharmaceutical Companies of Johnson & Johnson for the treatment of multiple sclerosis (MS). Based on the results of the phase III OPTIMUM trial, ponesimod was recently approved in the USA for the treatment of relapsing forms of MS and has received a positive CHMP opinion in the EU for this indication. This article summarizes the milestones in the development of ponesimod leading to this first US approval.
机译:Ponesimod(PONVORY(TM))是强生杨森制药公司为治疗多发性硬化症(MS)开发的口服选择性鞘氨醇-1-磷酸(S1P)受体1(S1P(1))激动剂。根据III期优化试验的结果,ponesimod最近在美国被批准用于治疗复发性MS,并且在欧盟获得了CHMP对此适应症的积极意见。这篇文章总结了ponesimod开发过程中的里程碑,这是美国第一次批准ponesimod。

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