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Takeda Pharmaceuticals (Takeda) recently announced that the European Medicines Agency (EMA) has accepted the application documents for its dengue vaccine TAK-003, which is being developed for people aged 4-60 to prevent dengue fever caused by any dengue virus serotype (Dengue).
Takeda will participate in the first-ever parallel evaluation of EU medical products conducted by EMA, and countries outside the EU will conduct the evaluation through the EU-M4all (formerly Article 58) procedure.
TAK-003 is an attenuated quadrivalent dengue vaccine, developed based on the attenuated dengue serotype 2 virus (DENV-2), which provides a genetic backbone for all four vaccine viruses.
Derek Wallace, Takeda Dengue Global Project Leader and Vice President, said: “Submitting regulatory documents for our dengue vaccine TAK-003 marks an important development for people living in or traveling to communities threatened by dengue fever.
TAK-003's regulatory documents include 36-month long-term safety and efficacy data from the ongoing pivotal Phase 3 Dengue Tetravalent Immunity Study (TIDS) trial.
Dengvaxia: The world's first dengue vaccine, produced by Sanofi
At present, there is only one dengue vaccine product on the market in the world, that is, Dengvaxia, a vaccine product developed by the French pharmaceutical giant Sanofi over 20 years.
Dengue fever (Dengue) is an acute vector-borne disease caused by the transmission of dengue virus through mosquitoes.
Dengue fever, commonly known as "breakbone fever", is the fastest-spreading mosquito-borne viral disease and is one of the top ten global health threats to the World Health Organization (WHO) in 2019.
Dengue fever is easily endemic, with outbreaks in tropical and subtropical regions, and recently also caused outbreaks in the continental United States and parts of Europe.
Currently, dengue hemorrhagic fever does not have any targeted treatment drugs.
Original source: Takeda Begins Regulatory Submissions for Dengue Vaccine Candidate in EU and Dengue-Endemic Countries