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.
Takeda Pharmaceutical Co. Ltd. has announced the withdrawal of a US Biologics License Application (BLA) for its dengue vaccine TAK-003, filed last November for the prevention of disease caused by any serotype in individuals aged four to 60.
The firm explained it voluntarily pulled the BLA from the review process following discussions with the Food and Drug Administration...
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