Takeda's Dengue Vaccine Candidate Under FDA Priority Review

  • The FDA has accepted and granted priority review to Takeda Pharmaceutical Co Ltd's TAK Biologics License Application (BLA) for TAK-003, the company's investigational dengue vaccine candidate. 
  • In the U.S., TAK-003 is being evaluated for the prevention of dengue disease caused by any dengue virus serotype in individuals four years through 60 years of age.
  • Dengue is a mosquito-borne virus endemic in more than 125 countries.
  • The TAK-003 application is supported by safety and efficacy data from the pivotal Phase 3 trial. The dengue vaccine candidate met its primary endpoint by preventing 80.2% of symptomatic dengue cases at 12 months.
  • In addition, TAK-003 prevented 90.4% of hospitalizations at 18 months and, in an exploratory analysis, demonstrated protection against dengue fever through 4.5 years (54 months) after vaccination. 
  • Exploratory analyses showed that throughout the 4.5-year study follow-up, TAK-003 prevented 84% of hospitalized dengue cases and 61% of symptomatic dengue cases in the overall population, including both seropositive and seronegative individuals.
  • TAK-003 has not been approved by the FDA or any other health authority outside of Indonesia.
  • In October 2022, the Committee for Medicinal Products for Human Use of the European Medicines Agency recommended the approval of TAK-003.
  • Price Action: TAK shares closed at $14.23 on Tuesday.
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