FDA accept filing for TAK 003 and grant priority review for Dengue
Takeda announced that the FDA has accepted and granted priority review of the 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 4 years through 60 years of age.
The TAK 003 BLA is supported by safety and efficacy data from the pivotal Phase III Tetravalent Immunization against Dengue Efficacy Study (TIDES) trial, where the dengue vaccine candidate met its primary endpoint by preventing 80.2% of symptomatic dengue cases at 12 months. In addition, TAK 003 met its secondary endpoint by preventing 90.4% of hospitalizations at 18 months, and in an exploratory analysis, it demonstrated protection against dengue fever through 4.5 years (54 months) after vaccination. The TIDES 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.
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