Data For Teva's Azilect Not Good Enough For Claim Of Slowing Parkinson's Progression, FDA Panel Says
This article was originally published in The Pink Sheet Daily
Executive Summary
FDA advisory committee reluctant to set precedent for disease modification indication without strong data.
You may also be interested in...
Teva Preserves Azilect’s Patent Even After FDA Rejects Indication
Court rules Mylan failed to prove the Azilect patent is invalid; expert testifies drug is “more likely than not” to slow Parkinson’s disease progression, even if FDA remains unconvinced.
Parkinson Drugs Need Better Trial Designs For Progression Claims, Advisory Panel Finds
Use of linear analysis in a randomized-start trial is problematic for drugs for Parkinson’s disease, the Peripheral and Central Nervous System Drugs Advisory Committee told FDA Oct. 17.
Parkinson Drugs Need Better Trial Designs For Progression Claims, Advisory Panel Finds
Use of linear analysis in a randomized-start trial is problematic for drugs for Parkinson’s disease, the Peripheral and Central Nervous System Drugs Advisory Committee told FDA Oct. 17.