Additionally, Takeda is participating in the EMA's first-ever parallel assessment of a medicinal product for use in the EU and in the EU-M4all (previously Article 58) procedure for countries outside of the EU. That means national regulators will conduct their own assessments to determine if national marketing authorizations for TAK-003 are granted. Takeda is also seeking TAK-003 approval in dengue-endemic countries not participating in the EU-M4all procedure.
The firm plans to submit regulatory filings in Argentina, Brazil, Colombia, Indonesia, Malaysia, Mexico, Singapore, Sri Lanka, and Thailand later this year. Submissions include long-term safety and efficacy data through 36 months from the ongoing phase III Tetravalent Immunization against Dengue Efficacy Study (TIDES) trial. Takeda said it plans to present and publish data regarding that trial sometime this year.
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