Takeda Still Hopeful On Dengue Vaccine Candidate

Company Says Loss Of EU Fast-Track Status Is 'Not Uncommon'

 
• By Maureen Kenny
  
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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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Dengue: The incidence of the mosquito-borne viral infection has risen dramatically in recent decades • Source: Alamy

Takeda Pharmaceutical hopes to find out by the end of fiscal year 2021 whether its tetravalent dengue vaccine candidate, TAK-003, is likely to be approved in the EU. The company declined to be more specific on potential approval timelines in the wake of the marketing authorization application (MAA) for TAK-003 losing its accelerated assessment status at the European Medicines Agency.

The EMA's Committee for Medicinal Products for Human Use (CHMP) began reviewing the MAA for TAK-003 under the accelerated assessment...

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