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EU Accelerated Assessment Tracker

Bayer and Takeda Fail In Quest For Fast-Track Review

 
• By Maureen Kenny

EU marketing authorization applications from Bayer for copanlisib and from Takeda for maribavir will be reviewed under standard timelines at the European Medicines Agency. 

This tracker provides information on accelerated assessment requests for planned marketing authorization applications (MAAs) that have come before the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for a decision. It also tracks whether companies retain fast-track status for MAAs as they make their way through the EU centralized procedure.

Fast-track review can cut a few months off the approximately 12 months it generally takes to review an application under...

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