Takeda Still Hopeful On Dengue Vaccine Candidate
Company Says Loss Of EU Fast-Track Status Is 'Not Uncommon'
Executive Summary
Takeda says loss of accelerated assessment status at EMA for marketing authorization application for its dengue vaccine candidate TAK-003 “was anticipated as a potential outcome.”
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EU Accelerated Assessment Tracker
The EU marketing authorization application for Takeda's dengue vaccine candidate is no longer being fast-tracked. Also, four requests for accelerated assessment were decided on at the latest meeting of the European Medicines Agency's drug evaluation committee, the CHMP.