Takeda pulls BLA for Dengue vaccine candidate TAK-003

12 July 2023

Japan’s largest drugmaker Takeda (TYO: 4502) today announced that it has voluntarily withdrawn the US Biologics License Application (BLA) for its dengue vaccine candidate, TAK-003 (Dengue tetravalent vaccine [live, attenuated]).

The decision follows discussions with the US Food and Drug Administration (FDA) on aspects of data collection, which cannot be addressed within the current BLA review cycle.

Takeda said that the future plan for TAK-003 in the USA will be further evaluated given the need for travelers and those living in dengue-endemic areas of the USA, such as Puerto Rico.

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