EU Accelerated Assessment Tracker
Takeda's Dengue Vaccine Candidate Reverts To Standard Review Timelines
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.
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In the first half of 2021, just six requests from companies seeking accelerated assessment of their planned EU marketing authorization applications were granted; 11 were rejected. The outcomes of five decided on in July and August are still unknown.
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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