Takeda Reports EMA’s Acceptance of TAK-003 for the Prevention of Dengue

March 26, 2021 Auto Bot Acceptance, EMA, Prevention, regulatory, reports, Takeda 0

Shots:

  • The submission is based on a P-III TIDES trial assessing TAK-003 (0.5ml, SC) vs PBO in 20,000+ healthy children & adolescents aged 4-16yrs. to prevent dengue fever of any severity and due to any of the four dengue virus serotypes
  • The trial met its 1EPs showed overall vaccine efficacy against VCD @12 mos. follow-up and all 2EPs @18 mos. follow-up. The results demonstrated TAK-003 was well-tolerated with no observed safety issue
  • The company plans to file for regulatory submission in the US and other countries during 2021. EMA to conduct first-ever parallel assessment for TAK-003 for use in the EU and through the EU-M4all procedure for countries outside of the EU

Click here ­to­ read full press release/ article | Ref: Takeda | Image: Moneycontrol

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