Takeda Pulls US BLA For Dengue Vaccine
Cites Issues Around 'Data Collection'
Despite a priority review being granted late last year by the FDA, Takeda has announced the surprise withdrawal of the US BLA for its dengue vaccine TAK-003, for reasons it said centered on "data collection" issues. The quadrivalent vaccine has already been approved as Qdenga in several other markets including the EU, Indonesia and Thailand and the future path in the US is currently uncertain.
