European Regulator Backs Approval Of Takeda's Dengue Vaccine

  • European Medicines Agency's Committee for Medicinal Products for Human Use recommended approving Takeda Pharmaceutical Co Ltd's TAK dengue vaccine candidate, TAK-003.
  • In August, Indonesia approved Takeda's dengue vaccine, Qdenga, for individuals six to 45 years.
  • The recommendation covers the dengue vaccine candidate to prevent dengue disease caused by any serotype in individuals four years of age and older in Europe and dengue-endemic countries.
  • The Committee's positive opinion was supported by results across five Phase 1, 2, and 3 trials with over 28,000 participants. 
  • This includes four and a half years of follow-up data from the global, pivotal Phase 3 TIDES trial, consistent with the World Health Organization's recommendation to obtain three to five years of follow-up data after completing a primary dengue vaccination to assess safety and efficacy accurately.
  • TIDES exploratory analyses showed that throughout the four and a half years of study follow-up, TAK-003 prevented 84% of hospitalized dengue cases and 61% of symptomatic dengue cases in the overall population.
  • TAK-003 has been generally well tolerated, with no evidence of disease enhancement in vaccine recipients.
  • Price Action: TAK shares are up 0.31% at $12.92 on the last check Friday.
  • Photo by Himas Rafeek from Pixabay
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Posted In: BiotechLarge CapNewsHealth CareGeneralBriefsEuropean Medicines Agency
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