TAK- 003 Recommended for the Prevention of Dengue Disease Caused by Any Dengue Contagion Serotype in individualities Four Times of Age and Aged in the EU and in Dengue- Endemic Countries sharing in the EU- M4all Procedure
Positive Opinion for TAK- 003 Grounded on4.5 Times of Safety and Efficacy Data from Pivotal Phase 3 Trial of Over,000 Children and Adolescents Across Eight Dengue-Aboriginal Countries
Marketing Authorization Anticipated in Coming Months in Europe Followed by Regulatory opinions in Latin America and Asia
Takeda( TSE4502/ NYSETAK) moment blazoned that the Committee for Medicinal Products for Human Use( CHMP) of the European Medicines Agency( EMA) recommended the blessing of Takeda’s dengue vaccine seeker, TAK- 003, for the forestallment of dengue complaint caused by any serotype in individualities four times of age and aged in Europe and in dengue-aboriginal countries sharing in the resemblant EU- M4all procedure. The final step in the path to blessing in Europe is Marketing Authorization from the EMA, which is anticipated in the coming months. Regulatory reviews will also progress in dengue-aboriginal countries in Latin America and Asia.
“ We’re one step closer towards the blessing of a dengue vaccine that could profit numerous of the millions of individualities around the world exposed to dengue. This is a major moment for the global health community, European countries and the dengue-aboriginal countries that shared in the EU- M4all procedure, ” said Gary Dubin,M.D., chairman of the Global Vaccine Business Unit at Takeda. “ We’ve been working for numerous times to help ameliorate the way dengue can be averted. Our sweats to give a new option for dengue forestallment support Takeda’s overall thing to give long- term societal value to the people we serve. ”
The prevalence of dengue has grown dramatically around the world in recent decades, causing an estimated 390 million infections and,000 hospitalizations annually.1, 2 The rise in cases can be attributed to factors similar as urbanization, globalization and climate change.1 Severe dengue accounts for about 5 of dengue cases and is a leading cause of serious illness and death among children and grown-ups in Latin America and Asia.3, 4 Dengue is the alternate most diagnosed cause of fever in trippers
returning to Europe from aboriginal countries.5 Its presence is far- reaching in aboriginal countries across the Americas, South- East Asia and Western Pacific regions and is growing innon-endemic areas in international Europe, including France, Italy, Germany, Spain and the United States.6
“ The global health community has been eager for a dengue vaccine that’s accessible without the hedge ofpre-vaccination testing, ” saidDr. Ooi Eng Eong, Professor of Emerging Infectious conditions at Duke- NUS Medical School in Singapore. “ The robust clinical data handed by Takeda shows that its dengue vaccine has the implicit to help help dengue cases and hospitalizations. moment, we’re near to helping ameliorate dengue forestallment and reducing the burden of complaint on countries, communities and health systems. ”
The Committee’s positive opinion was supported by results across five Phase 1, 2 and 3 trials with further than,000 children and grown-ups. This includes four and a half times of follow- up data from the global, vital Phase 3 Tetravalent Immunization against Dengue Efficacy Study( TIDES) trial, harmonious with the World Health Organization’s( WHO) recommendation to gain three to five times of follow- up data after the completion of a primary dengue vaccination in order to most directly assess safety and efficacity.7 runs exploratory analyses showed that throughout the four and a half times of study follow- up, TAK- 003 averted 84 of rehabilitated dengue cases and 61 of characteristic dengue cases in the overall population, including both seropositive and seronegative individualities. TAK- 003 has been generally well permitted, with no substantiation of complaint improvement in vaccine donors, and no important safety pitfalls have been linked in the TIDES trial, to date.
In August 2022, Takeda’s dengue vaccine, known as QDENGA ® ▼( Dengue Tetravalent Vaccine( Live, downgraded))( TAK- 003), was approved by the Indonesia National Agency for Drug and Food Control, BADAN POM, for the forestallment of dengue complaint by any serotype in individualities six times to 45 times of age. TAK- 003 has not yet been approved anywhere differently in the world and Takeda will continue to initiate and progress nonsupervisory forms in other dengue-aboriginal andnon-endemic countries.
Dengue is a mosquito- borne viral complaint that spreads fleetly around the world and was one of the WHO’s top 10 pitfalls to global health in2019.8 Dengue is substantially spread by Aedes aegypti mosquitoes and, to a lower extent, Aedes albopictus mosquitoes.1 It’s caused by any of four dengue contagion serotypes, each of which can beget dengue fever or severe dengue. The frequence of individual serotypes varies across different topographies, countries, regions, seasons and over time.2 Recovery from infection by one serotype provides lifelong impunity against only that serotype, and latterly exposure to any of the remaining serotypes is associated with an increased threat of severe complaint.1
Takeda is a global, values- grounded, R&D- driven biopharmaceutical leader headquartered in Japan, committed to discover and deliver life- transubstantiating treatments, guided by our commitment to cases, our people and the earth. Takeda focuses its R&D sweats on four remedial areas Oncology, Rare Genetics and Hematology, Neuroscience, and Gastroenterology( GI). We also make targeted R&D investments in Tube- deduced curatives and Vaccines. We’re fastening on developing largely innovative drugs that contribute to making a difference in people’s lives by advancing the frontier of new treatment options and using our enhanced cooperative R&D machine and capabilities to produce a robust, modality-different channel. Our workers are committed to perfecting quality of life for cases and to working with our mates in health care in roughly 80 countries and regions.