(Reuters) – Takeda Pharmaceutical Co 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.
Sanofi’s Dengvaxia, the world’s first dengue vaccine, was licensed in 2015. But the use of the French drugmaker’s vaccine was scaled back considerably after it emerged that it increased the risk of severe disease in “seronegative” children — those who had no prior dengue exposure when they got the shot.
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.
(Reporting by Sriparna Roy in Bengaluru; Editing by Shilpi Majumdar)
