Takeda Still Hopeful On Dengue Vaccine Candidate

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 mechanism on 25 March but the MAA reverted to standard review in June.Also see "EU Accelerated Assessment Tracker" - Pink Sheet, 30 July, 2021