Takeda gets a first approval for QDENGA, its dengue vaccine, which has been given the green light by the Indonesian National Agency for Drug and Food Control, Badan Pengawas Obat dan Makanan (BPOM), making it the only dengue vaccine approved in the country for use in individuals aged 6 to 45, regardless of previous dengue exposure and without the need for pre-vaccination testing.
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.
Gary Dubin, president of Takeda’s Vaccine Business Unit
A first for Indonesia and for Takeda
This is encouraging news for Indonesia. Hit with almost half of Southeast Asia’s dengue cases in recent years, the country continues to have one of the largest burdens in the world, reporting 63,000 dengue cases and nearly 600 deaths in the first half of 2022 alone.
The approval is also a first for Takeda as QDENGA has not yet been approved in other countries. The vaccine is currently undergoing regulatory review in the European Union (EU) and in dengue-endemic countries outside the EU through the EU-Medicines for all (EU-M4all) procedure.
EU-Medicines for all
EU-M4all is designed to facilitate patient access to essential medicines or vaccines intended to prevent or treat diseases of major public health interest and through this procedure (formerly Article 58), the European Medicines Agency (EMA), in cooperation with the WHO, can provide scientific opinion on medicines and vaccines for public health priority diseases for markets outside of the EU.
“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,” said Gary Dubin, president of Takeda’s Vaccine Business Unit.
The approval of QDENGA is based on the results across three years after vaccination from an ongoing Phase 3 trial that enrolled over 20,000 healthy children and adolescents ages four to 16 living in dengue-endemic areas in Asia and Latin America. Dengue, a mosquito-borne viral disease that is prevalent in over 125 countries, was deemed one of the top 10 threats to global health by the World Health Organization(WHO) in 2019.