Takeda’s Dengue vaccine gets approval recommendation from EMA

According to experts, the cases of dengue has grown dramatically around the world in recent decades, causing an estimated 390 million infections and 500,000 hospitalisations annually.

As per official data, the southern part of the City of Joy (Kolkata) has contributed 86 per cent of the total number of dengue cases reported from the metropolis in the last week.

Takeda, a Japanese multinational pharmaceutical company, on Monday announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended the approval of Takeda’s dengue vaccine candidate, TAK-003.

According to the pharma company, the vaccine is for the prevention of dengue disease caused by any serotype in individuals four years of age and older in Europe and in dengue-endemic countries participating in the parallel EU-M4all procedure.

In a statement, the company stated that the final step in the path to approval in Europe is Marketing Authorization from the EMA, which is expected in the coming months. Regulatory reviews will also progress in dengue-endemic countries in Latin America and Asia.

“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. We have been working for many years to help improve the way dengue can be prevented. Our efforts to provide a new option for dengue prevention support Takeda’s overall goal to provide long-term societal value to the people we serve,” said Gary Dubin, M.D., president of the Global Vaccine Business Unit at Takeda in a statement.

According to experts, the cases of dengue has grown dramatically around the world in recent decades, causing an estimated 390 million infections and 500,000 hospitalizations annually.

Studies have pointed out that the rise in cases can be attributed to factors such as urbanisation, globalisation and climate change.

Meanwhile, severe dengue accounts for about 5 percent of dengue cases and is a leading cause of serious illness and death among children and adults in Latin America and Asia.

It is noteworthy that Dengue is the second most diagnosed cause of fever in travelers returning to Europe from endemic countries. Reportedly, the presence of the disease is far-reaching in endemic countries across the Americas, South-East Asia and Western Pacific regions and is growing in non-endemic areas in continental Europe, including France, Italy, Germany, Spain and the United States.

“The Committee’s positive opinion was 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 3 Tetravalent Immunization against Dengue Efficacy Study (TIDES) trial, consistent with the World Health Organization’s (WHO) recommendation to obtain three to five years of follow-up data after the completion of primary dengue vaccination in order to most accurately assess safety and efficacy,” the company stated on Monday.

The study showed that throughout the four and a half years of study follow-up, TAK-003 prevented 84 percent of hospitalised dengue cases and 61 percent of symptomatic dengue cases in the overall population, including both seropositive and seronegative individuals, the company claimed.

“TAK-003 has been generally well tolerated, with no evidence of disease enhancement in vaccine recipients, and no important safety risks have been identified in the TIDES trial, to date,” the pharma company claimed.

In August this year, Takeda’s dengue vaccine, known as QDENGA (TAK-003), was approved by the Indonesia National Agency for Drug and Food Control, for the prevention of dengue disease by any serotype in individuals six years to 45 years of age.

ALSO READ | Takeda’s Dengue vaccine candidate provides extended protection through 4.5 Years in clinical trial

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First published on: 17-10-2022 at 15:57 IST
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