Takeda gets QDENGA EC approval as dengue vaccine

Takeda has received the European Commission‘s (EC) marketing authorization for the company’s dengue vaccine QDENGA (Dengue Tetravalent Vaccine [Live, Attenuated]) (TAK-003).

The QDENGA vaccine is indicated for use in individuals aged four and above in the European Union (EU) to prevent any of the four dengue serotypes.

The approval from the EC was backed by findings from Tetravalent Immunization against Dengue Efficacy Study (TIDES) trial, which showed prevention of 80.2% of symptomatic dengue cases 12 months after vaccination.

The trial results have also shown QDENGA to prevent 90.4% of hospitalizations 18 months after vaccination.

In addition, TAK-003 reported to have prevented 84% of hospitalized dengue cases and 61% of symptomatic dengue cases in the total population, including both seropositive and seronegative individuals throughout the 4.5-year study follow-up.

Gary Dubin — Takeda Global Vaccine Business Unit MD and president, commenting on QDENGA EC approval, said: “The European Commission’s approval marks an important turning point for QDENGA as we are one step closer to achieving our aspiration to help reduce the global burden of dengue.”

QDENGA was assessed across 19 phase 1, phase 2, and phase 3 clinical trials, and more than 28,000 children and adults, including the phase 3 TIDES trial.

The vaccine is said to be the only dengue shot cleared in the EU for use in people with prior dengue exposure.

QDENGA vaccine is reported to be made available in certain European nations by early 2023.

The vaccine is approved in Indonesia while regulatory filings continue to progress in other Asian and Latin American countries.