Ponesimod: First Approval

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.

Automated summary

Ponesimod, an oral selective sphingosine-1-phosphate receptor 1 (S1P(1)) agonist, has been approved for the treatment of relapsing forms of multiple sclerosis (MS) in the USA based on the results of the phase III OPTIMUM trial. This marks a significant milestone in the development of Ponesimod.