"Takeda is committed to applying innovation to tackle some of the world's most challenging infectious diseases and today we are very close to making that a reality with a dengue vaccine candidate," said Mr Peter Streibl, General Manager, Takeda Thailand. "Thailand is one of the top five most highly endemic countries in the world1 and the country's burden of dengue collectively represented over 60% of the total economic burden2,8. Vaccine development to transform the way dengue can be prevented will help ease the burden of both healthcare system and the economy in the endemic countries and beyond."
The incidence of dengue has grown dramatically around the world in recent decades, causing an estimated 390 million infections and 500,000 hospitalizations annually.3,4 In the past 15 years, more than 1.2 million people suffered and lost their lives from dengue in Thailand5. The rise in cases can be attributed to factors such as urbanization, globalization and climate change.3 Severe dengue accounts for about 5% of dengue cases and is a leading cause of serious illness and death among children and adults in Latin America and Asia.3,4 Dengue is the second most diagnosed cause of fever in travelers returning to Europe from endemic countries.5 Its presence is far-reaching in endemic countries across the Americas, South-East Asia and Western Pacific regions and is growing in non-endemic areas in continental Europe, including France, Italy, Germany, Spain and the United States.6
The Committee's positive opinion was supported by results across five Phase 1, 2 and 3 trials with more than 28,000 children and adults. This includes four and a half years of follow-up data from the global, pivotal Phase 3 Tetravalent Immunization against Dengue Efficacy Study (TIDES) trial, satisfying the World Health Organization's (WHO) recommendation to obtain three to five years of follow-up data after the completion of a primary dengue vaccination in order to most accurately assess safety and efficacy.7 Throughout the four and a half years of study follow-up, TAK-003 prevented 84% of hospitalized dengue cases and 61% of symptomatic dengue cases in the overall population, including both seropositive and seronegative individuals. TAK-003 has been generally well tolerated, with no evidence of disease enhancement in vaccine recipients, and no important safety risks have been identified in the TIDES trial, to date.
Dengue is a mosquito-borne viral disease that spreads rapidly around the world and was one of the WHO's top 10 threats to global health in 2019.7 Dengue is mainly spread by Aedes aegypti mosquitoes and, to a lesser extent, Aedes albopictus mosquitoes.3 It is caused by any of four dengue virus serotypes, each of which can cause dengue fever or severe dengue. The prevalence of individual serotypes varies across different geographies, countries, regions, seasons and over time.4 Recovery from infection by one serotype provides lifelong immunity against only that serotype, and later exposure to any of the remaining serotypes is associated with an increased risk of severe disease.3
About EU-M4all
EU-M4all (or EU-Medicines for all) is a procedure designed to facilitate patient access to essential medicines or vaccines intended to prevent or treat diseases of major public health interest. Through the EU-M4all procedure (previously known as the Article 58 procedure), the EMA, in cooperation with the World Health Organization (WHO), can provide scientific opinion on medicines and vaccines for public health priority diseases that are intended for markets outside of the EU.
About the Phase 3 TIDES (DEN-301) Trial
The double-blind, randomized, placebo-controlled Phase 3 Tetravalent Immunization against Dengue Efficacy Study (TIDES) trial is evaluating the safety and efficacy of two doses of TAK-003 in the prevention of laboratory-confirmed symptomatic dengue fever of any severity and due to any of the four dengue virus serotypes in children and adolescents. The TIDES trial is Takeda's largest interventional clinical trial to date and enrolled over 20,000 healthy children and adolescents ages four to 16 years living in dengue-endemic areas. Study participants were randomized 2:1 to receive two doses of TAK-003 0.5 mL or placebo on Months 0 and 3, administered subcutaneously. The study is comprised of five parts. Part 1 and the primary endpoint analysis evaluated vaccine efficacy (VE) and safety through 12 months after the second dose. Part 2 continued for an additional six months to complete the assessment of the secondary endpoints of VE by serotype, baseline serostatus and disease severity, including VE against hospitalized dengue. Part 3 evaluated VE and long-term safety by following participants for an additional two and a half to three years, as per WHO recommendations. Part 4 will evaluate efficacy and safety for 13 months following booster vaccination and Part 5 will evaluate long-term efficacy and safety for one year after completion of Part 4.
The trial is taking place at sites in dengue-endemic areas in Latin America (Brazil, Colombia, Panama, the Dominican Republic and Nicaragua) and Asia (Philippines, Thailand and Sri Lanka) where there are unmet needs in dengue prevention and where severe dengue is a leading cause of serious illness and death among children. 4 Baseline blood samples were collected from all individuals participating in the trial to allow for evaluation of safety and efficacy based on serostatus. Takeda and an independent Data Monitoring Committee of experts are actively monitoring safety on an ongoing basis.
Medical information
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About Takeda Pharmaceutical Company
Takeda is a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan, committed to discover and deliver life-transforming treatments, guided by our commitment to patients, our people and the planet. Takeda focuses its R&D efforts on four therapeutic areas: Oncology, Rare Genetics and Hematology, Neuroscience, and Gastroenterology (GI). We also make targeted R&D investments in Plasma-Derived Therapies and Vaccines. We are focusing on developing highly innovative medicines that contribute to making a difference in people's lives by advancing the frontier of new treatment options and leveraging our enhanced collaborative R&D engine and capabilities to create a robust, modality-diverse pipeline. Our employees are committed to improving quality of life for patients and to working with our partners in health care in approximately 80 countries and regions.
About Takeda Thailand
Takeda Thailand was established in 1969 as the second affiliated office outside of Japan. Takeda Thailand's core business portfolio includes innovations that can transform patients' lives under key business areas: Gastro-enterology, Oncology, Rare Genetic and Immunology, and preparing for the anticipated launch of Vaccines.
Source: FleishmanHillard Thailand