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

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

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

Shots:

  • 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

Click here to­ read the full press release 

Neha

Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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