Health
Dengue Vaccine Candidates Seek European Approval — Precision Vaccination
The European Medicines Agency (EMA) accepts Takeda Pharmaceutical Company Limited’s filing package for dengue vaccine candidate (TAK-003), which is being investigated to prevent dengue fever from dengue virus serotypes in individuals aged 4 to 60 years. I did.
Dengue is the fastest-growing mosquito-borne viral disease and was one of the World Health Organization’s major global health risks in 2019. Dengue causes 390 million infectious diseases each year and is estimated to kill about 20,000 people worldwide.
Takeda is a press release issued on March 25, 2021. TAK-003 In 2021, it was held in Argentina, Brazil, Colombia, Indonesia, Malaysia, Mexico, Singapore, Sri Lanka and Thailand.
Vice President Derek Wallace, Takeda’s Global Program Leader for Dengue Fever, said:
“The outbreak of dengue, which results in the hospitalization of 500,000 people worldwide each year, can overwhelm communities and governments as it has widespread impact on the healthcare system.”
“There is an urgent need for a widely available dengue vaccine with limited options to prevent disease. Takeda will work with regulators to support the evaluation of submissions and access to TAK-003. We are working to recommend an institution to achieve this. “
In addition, Takeda announced that it is participating in the first parallel assessment by the EMA through medicines used in the European Union (EU) and EU-M4all (formerly Article 58) procedures in countries other than the EU. Did.
In addition to the scientific opinion issued by the Commission on Human Medicine, national regulators of countries participating in the EU-M4all procedure can determine whether TAK-003 has been granted domestic marketing approval. We will carry out an evaluation.
Takeda is also seeking approval for TAK-003 in dengue endemic countries that have not participated in the EU-M4all procedure.
The TAK-003 regulatory submission contains long-term safety and efficacy data from the important ongoing Phase 3 Dengue Fever Efficacy Study (TIDES) study to 36 months. Takeda plans to publish and publish 36-month data details in academic societies and peer-reviewed journals in 2021.
Takeda will also submit regulatory filings in the United States, followed by additional countries in Asia and Latin America.
Takeda’s TAK-003 vaccine is based on an attenuated dengue serotype 2 virus that provides a genetic “backbone” for all four vaccine viruses.
Phase 2 clinical data for children and adolescents showed that TAK-003 induced an immune response against all four dengue serotypes in both seropositive and seronegative participants and persisted for 48 months after vaccination. Vaccines have generally been shown to be safe and well tolerated.
The critical Phase 3 TIDES trial included a 12-month follow-up with a virologically confirmed primary endpoint of overall vaccine efficacy (VE) for dengue fever and a sufficient number of cases of dengue fever, including VE. There was an 18-month follow-up that met all secondary endpoints. For inpatient dengue and VE in baseline seropositive and baseline seronegative individuals. Efficacy depends on the serotype.
Takeda Pharmaceutical Company Limited, a global value-based R & D-led biopharmacy leader headquartered in Japan, discovers life-changing therapies based on its commitment to patients, people and the planet. We are working on providing. For more information, please visit: Takeda vaccine..
Precision Vaccinations Publish research-based vaccine news.
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