FDA Grants Priority Review of BLA for Dengue Vaccine

An FDA decision on Takeda’s dengue vaccine TAK-003 is expected within six months.

The FDA has granted priority review of the Takeda’s biologics license application (BLA) for TAK-003, the company’s investigational dengue vaccine candidate. TAK-003 is being evaluated for the prevention of dengue disease caused by any dengue virus serotype in people 4 years through 60 years of age.

Dengue is a mosquito-borne virus endemic in more than 125 countries, including the U.S. territories of Puerto Rico, the U.S. Virgin Islands and American Samoa. Incidence of dengue has increased globally over the past two decades and is a leading cause of fever among travelers returning from Latin America, the Caribbean and Southeast Asia.

“This year, of the 888 dengue infections in the United States, 96% were a result of travel to dengue endemic areas. Of the 316 dengue infections in U.S. endemic territories, 97% were locally transmitted,” Gary Dubin, M.D., president of the Global Vaccine Business Unit at Takeda, said in a press release.

The 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% of symptomatic dengue cases at 12 months. In addition, TAK-003 met its secondary endpoint by preventing 90.4% of hospitalizations at 18 months, and in an exploratory analysis, it demonstrated protection against dengue fever through 4.5 years (54 months) after vaccination.

Safety results from the studies’ integrated analysis showed that the rates of serious adverse events were 6.21% in the TAK-003 group, and 7.56% in the placebo group. Most frequent events were nasopharyngitis, upper respiratory tract infection, viral upper respiratory tract infection, viral infection, and pyrexia.

Takeda’s tetravalent dengue vaccine candidate is based on a live-attenuated dengue serotype 2 virus, which provides the genetic backbone for all four vaccine viruses. It was approved in Indonesia in August 2022 with the brand name Qdenga, and in October 2022, the Committee for Medicinal Products for Human Use of the European Medicines Agency recommended its approval.