Dengue Vaccine Candidate Seeks Europe’s Approval

The European Medicines Agency (EMA) has accepted Takeda Pharmaceutical Company Limited’s filing packages for its dengue vaccine candidate (TAK-003), which is being investigated to prevent dengue due to any dengue virus serotype in individuals ages four to 60.

Dengue is the fastest spreading mosquito-borne viral disease and was one of the World Health Organization’s leading global health risks in 2019. Dengue is estimated to cause 390 million infections and around 20,000 fatalities globally each year.

Takeda stated in a press release issued on March 25, 2021, it intends to submit regulatory filings for TAK-003 in Argentina, Brazil, Colombia, Indonesia, Malaysia, Mexico, Singapore, Sri Lanka, and Thailand during 2021.

“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, VP, Dengue Global Program Leader at Takeda. 

“Dengue outbreaks, which result in half a million hospitalizations 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.”

Furthermore, Takeda announced it 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, national regulators in countries participating in the EU-M4all procedure will conduct their assessments to determine if national marketing authorizations 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 during 2021.

Takeda also intends to submit regulatory filings in the United States, followed by additional countries in Asia and Latin America.

Takeda's TAK-003 vaccine is based on a live-attenuated dengue serotype 2 virus, which provides the genetic “backbone” for all four vaccine viruses. 

Clinical Phase 2 data in children and adolescents showed that TAK-003 induced immune responses against all four dengue serotypes in both seropositive and seronegative participants, which persisted through 48 months after vaccination, and the vaccine was found to be generally safe and well-tolerated.

The pivotal Phase 3 TIDES trial met its primary endpoint of overall vaccine efficacy (VE) against virologically confirmed dengue at 12 months follow-up and all secondary endpoints at 18 months follow-up for which there were a sufficient number of dengue cases, including VE against hospitalized dengue and VE in baseline seropositive and baseline seronegative individuals. Efficacy varied by serotype. 

Takeda Pharmaceutical Company Limited is a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan, committed to discover and deliver life-transforming treatments, guided by our commitment to patients, our people, and the planet. For more information, visit Takeda Vaccines.

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