Takeda’s dengue vaccine candidate, Qdenga (TAK-003), has been approved by the European Commission (EC) for the prevention of dengue disease in individuals aged four years and over, the company announced.
The decision makes Qdenga the only dengue vaccine approved in the EU for use in individuals regardless of previous dengue exposure.
The EC’s approval, which follows the positive recommendation from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) in October this year, was supported by results across 19 phase 1, 2 and 3 trials with more than 28,000 children and adults.
This included four and a half years of follow-up data from the global pivotal phase 2 Tetravalent Immunization against Dengue Efficacy Study (TIDES) which showed that throughout the duration of the follow-up, Qdenga prevented 84% of hospitalised dengue cases and 61% of symptomatic dengue cases in the overall population, including both seropositive and seronegative individuals.
In terms of safety, the vaccine has been generally well tolerated, the company reported, with no evidence of disease enhancement in vaccine recipients and no important safety risk identified in the TIDES trial to date.
The worldwide incidence of dengue, a mosquito-borne viral disease, has grown dramatically in recent decades. A vast majority of cases are asymptomatic or mild and self-managed, and therefore the actual numbers of dengue cases are under-reported. Many cases are also misdiagnosed as other febrile illnesses.
The World Health Organization has reported that one modelling estimate indicates 390 million dengue virus infections per year, of which 96 million manifest clinically. Another study on the prevalence of dengue estimates that 3.9 billion people are at risk of infection with dengue viruses.
“With the increasing ease of travel today, our once expansive world has become that much smaller, increasing the risk of dengue disease for those living in dengue-endemic areas and for those travelling to these regions,” said Gary Dubin, president of the global vaccine business unit at Takeda.
He continued: “The EC’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. We are proud to introduce Qdenga in many parts of the EU, offering healthcare providers a new tool in dengue prevention for their patients living in the EU and travelling to endemic regions around the world.”