EU, US Reviewers Differed On Ponvory’s Secondary Endpoints, But Hierarchy Didn’t Matter In The End
Janssen went against EMA’s advice on the choice of secondary endpoints for its multiple sclerosis drug Ponvory (ponesimod), but still enjoyed a relatively brisk review. The hierarchical order of endpoints did not seem to ruffle any feathers among US FDA reviewers.
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Janssen’s ponesimod for relapsing multiple sclerosis had a slightly faster review in the US.
The health technology assessment body for England and Wales (NICE) has reversed its initial rejection of Ponvory, giving people with relapsing-remitting multiple sclerosis a new oral treatment option.
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