Takeda’s Dengue Vaccine Candidate Gets Thumbs Up From EMA Panel
The EMA’s Committee for Medicinal Products for Human Use has recommended approval of Takeda’s tetravalent dengue vaccine candidate TAK-003 for individuals four years of age and older in Europe and in dengue-endemic countries.
The EMA panel commented that although there is already an approved vaccine for the disease caused by the dengue virus, TAK-003 exhibited wider protection for young children and individuals older than 45.
The committee’s opinion was supported by results from five phase 1, 2 and 3 trials with about 28,000 children and adults, and four and a half years of follow-up data. The shot was shown to help prevent fever, severe disease and hospitalization triggered by any of the four serotypes of the dengue virus.
Takeda said it anticipates a marketing authorization from the European Commission in the coming months, adding that regulatory reviews will also progress in dengue-endemic countries in Latin America and Asia.
The incidence of dengue has grown dramatically in recent decades, causing an estimated 390 million infections and 500,000 hospitalizations annually.