Takeda’s dengue vaccine candidate recommended for approval by CHMP

Takeda’s dengue vaccine candidate, TAK-003, has been recommended for conditional marketing authorisation for the prevention of dengue disease caused by any serotype in individuals four years and older in Europe and dengue-endemic countries participating in the parallel EU-M4all procedure, the company announced.

The incidence of dengue, a mosquito-borne viral disease, has grown dramatically in recent decades, resulting in an estimated 390 million infections and 500,000 hospitalisations each year. This rise in cases can be attributed to factors such as urbanisation, globalisation and climate change.

The decision from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) is supported by results across five phase 1, 2 and 3 trials with more than 28,000 children and adults.

This includes 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, TAK-003 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.

“We are one step closer towards the approval of a dengue vaccine that could benefit many of the millions of individuals around the world exposed to dengue. This is a major moment for the global health community, European countries and the dengue-endemic countries that participated in the EU-M4all procedure,” said Gary Dubin, president of the global vaccine business unit at Takeda.

Takeda’s dengue vaccine, known as QDENGA, was approved by the Indonesia National Agency for Drug and Food Control, BADAN POM, in August this year for the prevention of dengue disease by any serotype in individuals six to 45 years.

TAK-003 has not yet been approved anywhere else in the world, but the company has outlined its plans to continue to initiate and progress regulatory filings in other dengue-endemic and non-endemic countries.

Dr Ooi Eng Eong, professor of emerging infectious diseases at Duke-NUS Medical School in Singapore, said: “The robust clinical data provided by Takeda shows that its dengue vaccine has the potential to help prevent dengue cases and hospitalisations. Today, we are closer to helping improve dengue prevention and reducing the burden of disease on countries, communities and health systems.”