Takeda Pharmaceutical’s dengue fever vaccine Qdenga expanded its approval to Europe after approval in Indonesia in August.
As Takeda continues to apply for vaccine licenses in dengue epidemic countries in Asia and Latin America, European approval is likely to have a positive effect on future approvals from other regulatory agencies.
Takeda announced on the 8th (local time) that the European Commission has approved the marketing of Qdenga in the European Union for the prevention of dengue fever in adults and children aged 4 years and older.
Qdenga is the only dengue vaccine available regardless of previous dengue exposure and should be used according to official recommendations.
Dengue fever was named as one of the top 10 threats to global health for 2019 by the World Health Organization (WHO) and is 30 times more prevalent than it was 50 years ago, covering more than 125 countries. Over the past 20 years, the worldwide incidence has increased eight-fold.
The approval follows the positive advisory opinion of the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) issued last October.
The European Commission’s approval of Qdenga is based on the results of 19 phase 1, 2 and 3 clinical trials involving more than 28,000 children and adults. It includes four and a half years of follow-up data from the global pivotal phase 3 TIDES trial.
The TIDES trial met the primary endpoint of overall vaccine efficacy, showing that 80.2% of symptomatic dengue cases were prevented 12 months after two doses of the vaccine.
Qdenga also met key secondary endpoints, preventing 90.4% of hospitalizations after 18 months. Efficacy differed by serotype.
An exploratory analysis found that the vaccine prevented 84% of dengue hospitalizations and 61% of symptomatic dengue fever cases in the total population, including both seropositive and seronegative populations, over a 4.5-year follow-up period.
Vaccine tolerability was generally good, there was no evidence of disease enhancement in vaccinated persons, and no significant safety risks were found.
“European Commission approval is an important milestone for Qdenga, bringing us one step closer to achieving our aspiration to help reduce the global burden of dengue fever,” said Gary Durbin, President, Global Vaccines, Takeda.
Meanwhile, Qdenga was first approved in Indonesia in August of this year for the prevention of dengue against all serotypes for adults and children aged 6 to 45 years.