Takeda Reports the US FDA Acceptance of BLA for TAK-003 and Granted Priority Review for the Prevention of Dengue Disease


The US FDA has accepted the BLA of TAK-003 and granted priority review to prevent dengue disease caused by any dengue virus serotype in individuals aged 4-60yrs.
The BLA was based on the safety and efficacy data from the P-III (TIDES) trial evaluating the 2 doses of TAK-003 (0.5mL) at sites in dengue-endemic areas in Latin America & Asia. The trial met its 1EPs & 2EPs i.e., 80.2% reduction of symptomatic dengue cases @12mos. & 90.4% of hospitalizations @18mos.
In an exploratory analysis, the vaccine showed protection against dengue fever through 4.5yrs. after vaccination & prevents 84% of hospitalized dengue cases and 61% of symptomatic dengue in the overall population, incl. seropositive and seronegative individuals

Ref: Takeda | Image: Takeda