KUALA LUMPUR, March 30 — Takeda Pharmaceutical Company Limited announced that the European Medicines Agency (EMA) has accepted regulatory filings for its dengue vaccine candidate that seeks to prevent dengue infection from any virus serotype in individuals aged four to 60.
Takeda intends to submit regulatory filings in Malaysia, Singapore, Thailand, Indonesia, Argentina, Brazil, Colombia, Mexico, and Sri Lanka this year.
“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 Derek Wallace, Dengue Global Programme Leader at Takeda.
“Dengue outbreaks, which result in half a million hospitalisations globally each year, can overwhelm communities and governments because of the broad impact on the health care system.
“With limited options to prevent the disease, there is a pressing need for widely available dengue vaccines. Takeda is committed to working with regulatory authorities and recommending bodies to support evaluation of our submissions and achieve access for TAK-003,” he added.
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.
Takeda is also seeking approval of TAK-003 in dengue-endemic countries that are not participating in the EU-M4all procedure.
Regulatory submissions for TAK-003 include long-term safety and efficacy data through 36 months from the ongoing pivotal Phase 3 Tetravalent Immunization against Dengue Efficacy Study (TIDES) trial.
Takeda 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.