Health
EMA Committee Endorses Takeda’s Dengue Vaccine Candidate
The vaccine, TAK-003, has been approved by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for the prevention of serotype-associated dengue fever in individuals aged 4 years and older.
SCHOTT was evaluated through the EMA’s first-ever parallel evaluation of a medicinal product for use in the EU and non-EU countries according to the EU-M4all procedure. This provides participating regulatory bodies, many of whom are from dengue-endemic countries, with a scientific basis for making their own regulatory decisions.
Medicines submitted under the EU-M4all programme, will be evaluated by the CHMP in collaboration with WHO and the target countries, and the scientific review capabilities of the EMA and the epidemiological and community disease assessment of WHO, the target country experts and national regulatory authorities. Expertise combined.
More than half of the world’s population (approximately 4 billion people) are at risk of contracting dengue each year, and currently there are no effective preventive options for individuals, regardless of whether they have been previously infected with the disease. data naFrom the World Health Organization (WHO).
According to WHO data, dengue is the second most frequently diagnosed cause of fever in travelers returning to Europe from endemic countries, and severe dengue is the leading cause of serious illness and death among children in Latin America and Asia. This is the main cause.
The CHMP said its positive opinion of TAK-003, branded as Qdenga, was supported by results from five Phase 1, 2 and 3 trials involving more than 28,000 children and adults. This includes his 4.5-year follow-up data from the global pivotal Phase 3 Quadrivalent Immunization Efficacy Study (TIDES) against dengue fever.
Takeda said EMA marketing approval for the vaccine is expected in the coming months, followed by regulatory approvals in dengue-endemic countries in Latin America and Asia. Qdenga is already approved in Indonesia.
Dengue Vaccine Contractna
The world is turning its attention to research and development targeting dengue fever, and in July, reportnaIts British vaccine company, Emergex, has signed a joint agreement with Brazil’s Paraná Institute for Molecular Biology (IBMP) in a partnership covering dengue, COVID-19 and chikungunya vaccines.
The agreement includes a shared clinical development stage and IBMP’s exclusive rights to commercialize the vaccine candidate in Brazil. Additionally, clinical-stage manufacturing of the vaccine will be performed by Emergex. The transition to commercial scale manufacturing is being done in the region by IBMP.
The alliance will initially focus on Emergex’s dengue vaccine candidate. It is currently undergoing Phase 1 clinical trials in Switzerland, with top-notch results expected soon. This makes him one of the UK company’s most advanced candidates to use a 100% synthetic T-cell adaptive vaccine approach. Dengue vaccines show potential to modify diseases of members of other virus families in the Flaviviridae family, such as Zika and yellow fever.
Emergex also defends the potential for vaccine candidates to be ambient temperature stable, reducing administration burden and logistics.
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