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

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

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

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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Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

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