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Takeda : FDA Grants Priority Review Of BLA For Dengue Vaccine Candidate TAK-003

Takeda (TAK) said that the U.S. Food and Drug Administration has granted priority review of the Biologics License Application 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.

Dengue is a mosquito-borne virus endemic in more than 125 countries, including the U.S. territories of Puerto Rico, the U.S. Virgin Islands and American Samoa. Incidence of dengue has increased globally over the past two decades and is a leading cause of fever among travelers returning from Latin America, the Caribbean and Southeast Asia.

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