Japanese pharma major Takeda (TYO: 4502) announced the company’s dengue vaccine, Qdenga (dengue tetravalent vaccine [live, attenuated]; formerly known as TAK-003), was approved by the Indonesia National Agency for Drug and Food Control, Badan Pengawas Obat dan Makanan (BPOM), for the prevention of dengue disease caused by any serotype in individuals six years to 45 years of age. This is the first approval for the vaccine anywhere in the world.
The use of Qdenga should be in accordance with official recommendations. Qdenga is the only dengue vaccine approved in Indonesia for use in individuals regardless of previous dengue exposure and without the need for pre-vaccination testing. Takeda said last December that the vaccine could reach up to $1.6 billion in peak sales.
“Dengue can affect anyone living in or traveling to endemic areas - regardless of age, health and socio-economic circumstances,” said Gary Dubin, president of Takeda’s Vaccine Business Unit. “Developing this innovative dengue vaccine has been an exciting challenge, and its approval in Indonesia is an important achievement for Takeda and for public health. We’re proud to introduce Qdenga as a new dengue prevention tool to the people of Indonesia, and we will continue to work with additional regulatory agencies to make Qdenga available globally,” he added.
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