Takeda Withdraws FDA Application For Dengue Vaccine Candidate On Data Disagreement

Takeda Pharmaceutical Co Ltd TAK said on Tuesday that it was voluntarily withdrawing its marketing application for its dengue vaccine, TAK-003, candidate following discussions with the FDA.

The Japan-based company cited data collection issues, which cannot be addressed within the current review cycle.

The drugmaker said the future plan for the candidate, TAK-003, in the U.S. 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 vaccine, dubbed, Qdenga, is approved in Indonesia, Brazil, the European Union (EU), Iceland, the U.K., Norway, and Lichtenstein. 

Sanofi SA's SNY Dengvaxia, the world's inaugural dengue vaccine, obtained its license in 2015. 

However, it was revealed that the vaccine augmented the risk of severe disease among "seronegative" children - those who hadn't previously been exposed to dengue before receiving the vaccine, Reuters reported. As a result, the usage of Dengvaxia was significantly reduced.

In November last year, the FDA accepted and granted priority review to TAK-003.

In April, the United Nations' specialized agency, Pan American Health Organization (PAHO), was reportedly in early talks with Takeda regarding the potential orders of its dengue vaccine.

Price Action: TAK shares are up 0.15% at $15.54 premarket on the last check Wednesday.