EU recommends approval of Takeda’s dengue vaccine

Marketing authorization expected in the coming months in Europe, followed by regulatory decisions in Latin America and Asia

Japanese pharmaceutical company Takeda has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of Takeda’s dengue vaccine candidate, TAK-003, for the prevention of dengue disease caused by a serotype in individuals aged four years and older in Europe and dengue-endemic countries participation in the parallel EU-M4all procedure.

The final step in the approval process in Europe is the marketing authorization (MA) from the EMA, which is expected in the coming months. The regulatory review will also increase in dengue-endemic countries in Latin America and Asia.

The incidence of dengue fever has increased dramatically worldwide in recent decades, with an estimated 390 million infections and 500,000 hospitalizations per year. The increase in the number of cases is due to factors such as urbanization, globalization and climate change. Severe dengue accounts for approximately 5% of dengue cases and is a leading cause of serious illness and death in children and adults in Latin America and Asia.

“The global health community is eager for a dengue vaccine that is accessible without the barrier of pre-vaccination testing,” said Dr. Ooi Eng Eong, professor of emerging infectious diseases at Duke-NUS Medical School in Singapore. “Takeda’s robust clinical data shows that its dengue vaccine has the potential to help prevent dengue cases and hospitalizations. Today we are closer to helping improve dengue prevention and reduce the burden of disease on countries, communities and health systems.”

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