The Food and Drug Administration (FDA) has accepted for Priority Review the Biologics License Application (BLA) for TAK-003, an investigational tetravalent dengue vaccine.
TAK-003 is based on a live-attenuated dengue serotype 2 virus. The BLA is supported by data from the randomized, double-blind, placebo-controlled phase 3 TIDES trial (ClinicalTrials.gov Identifier: NCT02747927), which evaluated the efficacy and safety of TAK-003 in preventing symptomatic dengue fever of any severity and due to any of the 4 dengue virus serotypes in over 20,000 patients. Patients were randomly assigned to receive either TAK-003 or placebo subcutaneously on day 1 and 90.
Findings showed that TAK-003 met the primary endpoint by preventing 80.2% of symptomatic cases at 12 months. Moreover, the vaccine met the secondary endpoint by preventing 90.4% of hospitalizations at 18 months. Exploratory analyses also showed that the vaccine protected against dengue fever through 4.5 years after vaccination, preventing 84% of hospitalized dengue cases and 61% of symptomatic dengue cases in the overall population.
The most frequent adverse events reported with TAK-003 were nasopharyngitis, upper respiratory tract infection, viral upper respiratory tract infection, viral infection, and pyrexia.
“If approved, we believe TAK-003 has the potential to become an important dengue prevention option for health care providers, and we continue to be encouraged by our discussions with the FDA,” said Gary Dubin, MD, president of the Global Vaccine Business Unit at Takeda.
Takeda’s Biologics License Application (BLA) for dengue vaccine candidate (TAK-003) granted Priority Review by US Food and Drug Administration. News release. Takeda. Accessed November 22, 2022. https://www.businesswire.com/news/home/20221122005793/en/Takeda%E2%80%99s-Biologics-License-Application-BLA-for-Dengue-Vaccine-Candidate-TAK-003-Granted-Priority-Review-by-U.S.-Food-and-Drug-Administration.