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Ponesimod: First Approval

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posted on 2021-11-01, 01:23 authored by Anthony Markham

Declarations

Funding The preparation of this review was not supported by any external funding.

Authorship and Conflict of interest During the peer review process the manufacturer of the agent under review was offered an opportunity to comment on the article. Changes resulting from any comments received were made by the authors on the basis of scientific completeness and accuracy. A. Markham is a contracted employee of Adis International Ltd/Springer Nature, and declares no relevant conflicts of interest. All authors contributed to the review and are responsible for the article content. Ethics approval, Consent to participate, Consent to publish, Availability of data and material, Code availability Not applicable.

Additional information about this Adis Drug Review can be found here

Abstract

Ponesimod (PONVORY™) is an orally administered selective sphingosine-1-phosphate (S1P) receptor 1 (S1P1) 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.