DENGUE outbreaks, which have resulted in over half a million hospitalisations globally on an annual basis, can overwhelm communities and governments due to of the broad impact it can bring to the healthcare system.
With limited options to prevent the disease, there is a pressing need for widely available dengue vaccines.
In light of that, Takeda Pharmaceutical Company Ltd’s filing packages for its dengue vaccine candidate (TAK-003) has been accepted by the European Medicines Agency (EMA).
The TAK-003 is currently being investigated for the prevention of dengue due to any dengue virus serotype in individuals ages four to 60.
“Submission of regulatory filings for our dengue vaccine candidate, TAK-003, marks an important development for people who are living in or traveling to communities burdened by the threat of dengue,” said Takeda vice president and dengue global programme leader Derek Wallace.
He also revealed that Takeda intends to submit regulatory filings in Argentina, Brazil, Colombia, Indonesia, Malaysia, Mexico, Singapore, Sri Lanka and Thailand during 2021.
Apart from that, Takeda is participating in the EMA’s first-ever parallel assessment of a medicinal product for use in the European Union (EU), and through the EU-M4all (previously Article 58) procedure for countries outside of the EU.
Along with the scientific opinion issued by the Committee for Medicinal Products for Human Use (CHMP), national regulators in countries participating in the EU-M4all procedure will conduct their own assessments to determine if national marketing authorisations for TAK-003 are granted.
Regulatory submissions for TAK-003 include long-term safety and efficacy data through 36 months from the ongoing pivotal Phase 3 Tetravalent Immunisation against Dengue Efficacy Study (TIDES) trial.
The company intends to present and publish details of the 36-month data at a scientific meeting and in a peer-reviewed journal this year.
Takeda also intends to submit regulatory filings in the United States, followed by additional countries in Asia and Latin America. – Apr 3, 2021