FDA Grants Priority Review for Investigational Dengue Vaccine

The biopharmaceutical company Takeda recently announced that the US Food and Drug Administration (FDA) accepted and granted priority review of the Biologics License Application (BLA) for their investigational dengue vaccine, TAK-003.

The vaccine candidate is under evaluation for preventing disease caused by any dengue virus serotype in individuals 4-60 years of age.

“If approved, we believe TAK-003 has the potential to become an important dengue prevention option for healthcare providers, and we continue to be encouraged by our discussions with the FDA,” said Gary Dubin, MD, president of Takeda’s Global Vaccine Business Unit.

Dengue is a vector-borne disease, carried by mosquitoes and endemic in more than 125 countries. Over the last 20 years, dengue incidence has increased across the world. The virus is now a leading cause of fever among travelers to Latin America, Southeast Asia, and the Caribbean.

“This year, of the 888 dengue infections in the US, 96% were a result of travel to dengue endemic areas,” explained Dubin. “Of the 316 dengue infections in US endemic territories, 97% were locally transmitted. At Takeda, we are guided by our commitment to serving these affected populations.”

The BLA was accepted and granted priority review largely due to positive safety and efficacy data from the phase 3 clinical trial, Tetravalent Immunization against Dengue Efficacy Study (TIDES). TAK-003 met its primary endpoint, preventing 80.2% of symptomatic dengue cases after 12 months. The dengue vaccine candidate also met its secondary endpoint, preventing 90.4% of hospitalizations at 18 months.

Exploratory analyses suggest TAK-003 prevented dengue for 4.5 years (54 months) after vaccination. At the end of this 4.5-year follow-up, TAK-003 prevented 84% of hospitalized dengue cases and 61% of symptomatic infections in both seropositive and seronegative persons.

The rate of serious adverse events was 6.21% in the TAK-003 group and 7.56% in the placebo group. The most commonly reported adverse events were nasopharyngitis, upper respiratory tract infection, viral upper respiratory tract infection, viral infection, and pyrexia.

So far, TAK-003 is only approved in Indonesia. The tetravalent dengue vaccine candidate is based on a live-attenuated dengue serotype 2 virus, and acts as the genetic blueprint for all 4 vaccine viruses. Prior phase 2 trial data found TAK-003 elicited an immune response against all 4 dengue serotypes in seropositive and seronegative child and adolescent participants.

Dubin emphasized the potential of TAK-003, saying Takeda is “fully committed to to working with the FDA to advance this filing.”