English Reimbursement Win For Janssen’s Oral Multiple Sclerosis Drug
Ponvory Is Also Approved For Use On The NHS In Scotland
Executive Summary
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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In approving ponesimod for relapsing multiple sclerosis, neither the FDA nor EMA included in labeling data from a novel patient-reported outcomes fatigue instrument; FDA said the PRO was not shown to be capable of measuring within-patient change, while EMA said the difference relative to Sanofi’s Aubagio fell short of the threshold for a clinically meaningful benefit.
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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