The US Food and Drug Administration (FDA) has accepted and granted priority review of the Biologics Licence Application (BLA) for TAK-003, the company’s investigational dengue vaccine candidate. In the US, TAK-003 is being evaluated for the prevention of dengue disease caused by any dengue virus serotype in individuals four years through 60 years of age, Takeda said in a statement today.
“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. 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. At Takeda, we are guided by our commitment to serving these affected populations and are fully committed to working with the FDA to advance this filing,” said Gary Dubin, MD, President, Global Vaccine Business Unit, Takeda, in the statement.
The TAK-003 BLA is supported by safety and efficacy data from the pivotal phase-III Tetravalent Immunisation 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. In addition, TAK-003 met its secondary endpoint by preventing 90.4 per cent of hospitalisations at 18 months, and in an exploratory analysis, it demonstrated protection against dengue fever through 4.5 years (54 months) after vaccination. The TIDES exploratory analyses showed that throughout the 4.5-year study follow-up, TAK-003 prevented 84 per cent of hospitalised dengue cases and 61 per cent of symptomatic dengue cases in the overall population, including both seropositive and seronegative individuals, the statement noted.