Takeda’s dengue vaccine candidate’s filing packages has been accepted by the European Medicines Agency (EMA), which is being investigated for its prevention of dengue in individuals between the ages of 4 and 60. Takeda also submitted the vaccine for regulatory approval to dengue-epidemic countries like Malaysia, Singapore, Mexico, Indonesia, Colombia, Brazil, Sri Lanka, Argentina, and Thailand through the first-ever parallel assessment of the use of the medicinal product in the European Union through the EU-M4all procedure. Derek Wallace, VP, Dengue Global Program Leader at Takeda, stated, “Dengue outbreaks, which result in half a million hospitalizations globally each year, can overwhelm communities and governments because of the broad impact on the health care system. With limited options to prevent the disease, there is a pressing need for widely available dengue vaccines. Takeda is committed to working with regulatory authorities and recommending bodies to support evaluation of our submissions and achieve access for TAK-003.”
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