Path to approval. Takeda’s dengue vaccine candidate granted priority review by the USFDA 

An investigational dengue vaccine candidate from Takeda has been granted priority review by the United States Food and Drug Administration, the Japan-headquartered company said.

The Biologics License Application (BLA) for TAK-003, the dengue vaccine candidate, is being evaluated for the prevention of dengue, caused by any dengue virus serotype in individuals from four to 60 years.

Presently, only Indonesia has approved TAK-003. Following the Indonesia go-ahead, Takeda said it would continue with regulatory filings in other dengue-endemic and non-endemic countries. “Regulatory reviews will also progress in dengue-endemic countries in Latin America and Asia,” Takeda said.

In October 2022, 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, 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.

The final step in the path to approval in Europe is a Marketing Authorization decision from the EMA, which is expected in the coming months, a note from the company said.

Internationally, there is one other dengue vaccine from Sanofi Pasteur, but it is given only to those who had been previously infected with dengue.

Mosquito-borne

Dengue is a mosquito-borne virus, endemic to more than 125 countries, including the US regions of Puerto Rico, the US Virgin Islands and American Samoa, the company said. Incidence of dengue has increased globally over the past two decades and is a leading cause of fever among travellers returning from Latin America, the Caribbean and Southeast Asia, it added.ⁱ

Gary Dubin, Takeda’s president of the Global Vaccine Business Unit said, “This year, of the 888 dengue infections in the US, 96 per cent were a result of travel to dengue endemic areas. Of the 316 dengue infections in US endemic territories, 97 per cent were locally transmitted.”

Genetic backbone

Takeda’s tetravalent dengue vaccine candidate (TAK-003) is based on a live-attenuated dengue serotype 2 virus, which provides the genetic “backbone” for all four vaccine viruses, the company said.

The TAK-003 BLA is supported by safety and efficacy data from the pivotal Phase 3 Tetravalent Immunization against Dengue Efficacy Study (TIDES) trial, where the dengue vaccine candidate met its primary endpoint by preventing 80.2 per cent of symptomatic dengue cases at 12 months. It also met its secondary endpoint by preventing 90.4 per cent of hospitalizations at 18 months, and in an exploratory analysis, it demonstrated protection against dengue fever through 4.5 years (54 months) after vaccination, it added.