Takeda Pharmaceutical Co (4502.T) said on Tuesday it was voluntarily withdrawing its application for its dengue vaccine candidate, following discussions with the U.S. health regulator.
The Japan-based company cited data collection issues, which cannot be addressed within the current review cycle.
The future plan for the candidate, TAK-003, in the United States would be further evaluated, given the need for travelers and those living in dengue-endemic areas of the U.S., such as Puerto Rico, the drugmaker said.
Takeda's vaccine, branded as QDENGA, was authorized in the European Union last year for use in those aged 4 and older to prevent any of the four so-called serotypes of dengue.
It has also been approved in the United Kingdom, Brazil, Argentina, Indonesia, and Thailand, according to the company.
There are 3.1 million cases of the mosquito-borne viral infection in the U.S., with more than 25,000 classified as severe, according to estimates by the World Health Organization.
