TAK-003 has been developed based on a live-attenuated dengue serotype 2 virus that offers the genetic backbone for all four vaccine viruses.
It is currently being assessed to prevent dengue disease, which is caused by any dengue virus serotype in people aged four years to 60 years, in the US.
Takeda Global Vaccine Business Unit president Gary Dubin said: “If approved, we believe TAK-003 has the potential to become an important dengue prevention option for healthcare providers, and we continue to be encouraged by our discussions with the FDA.
“This year, of the 888 dengue infections in the U.S., 96% were a result of travel to dengue endemic areas. Of the 316 dengue infections in US endemic territories, 97% were locally transmitted.
“At Takeda, we are guided by our commitment to serving these affected populations and are fully committed to working with the FDA to advance this filing.”
The BLA submitted to the FDA is supported by the data obtained from the pivotal Phase III Tetravalent Immunization against Dengue Efficacy Study (TIDES) trial.
The study assessed the efficacy and safety of two TAK-003 doses for preventing lab-confirmed symptomatic dengue fever caused due to any of the four dengue virus serotypes in adolescents and children.
In the trial, TAK-003 met the primary endpoint by preventing 80.2% of symptomatic dengue cases at 12 months.
The vaccine candidate also met the secondary endpoint of the study by preventing 90.4% of hospitalisations at 18 months.
It also showed protection against dengue fever through 4.5 years following vaccination, in an exploratory analysis.
Takeda intends to continue regulatory filings for TAK-003 in other dengue-endemic and non-endemic countries, after receiving approval in Indonesia.