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Where FDA, EMA do and don’t agree in neurology
FDA has granted accelerated approval to seven neuroscience NMEs since 2016, none of which are approved in Europe
October 27, 2023 1:20 AM UTC
Updated on Jan 26, 2024 at 11:52 PM UTC
When it comes to neuroscience NMEs, FDA and EMA agree more often than not. But a handful of divergent decisions suggest different risk tolerances for expedited approvals.
Of the 61 NMEs approved since 2016 by CDER’s Office of Neuroscience or its predecessor offices — Division of Neurology Products, Division of Psychiatry Products and Division of Anesthesia, Analgesia, and Addiction Products — sponsors have sought European Commission approval for 44, of which 35 (80%) have been granted marketing authorization, including one that’s now been withdrawn in both territories. The median lag time between the two approvals of just under six months. ...