Takeda indicated that it could not address issues related to aspects of data collection within the current BLA review cycle.
Takeda has voluntarily withdrawn the U.S. biologics license application (BLA) for its dengue vaccine candidate, TAK-003. The company indicated in a statement that it could not address issues related to aspects of data collection within the current BLA review cycle. Takeda officials indicated they are evaluating next steps for the vaccine.
“Our clinical program was designed to account for the complex global nature of dengue, and data from our 4.5-year trial has built confidence in TAK-003’s ability to help provide long-term protection against dengue, with a positive benefit and risk profile regardless of baseline serostatus,” Gary Dubin, M.D., president of Takeda’s Vaccines Business Unit, said in a press release. “The urgent global need to combat the growing burden of dengue remains, and we will continue to progress regulatory reviews and provide access for people living in and traveling to dengue-endemic areas while we work to determine next steps in the U.S.”
Dengue is a mosquito-borne virus that spreads rapidly and is found in tropical climates. It is transmitted through the bite of the Aedes species of mosquito, which also spreads the Zika and chikungungya viruses.
Most people who get dengue won’t have symptoms. But for those that do, the most common symptoms are high fever, headache, body aches, nausea and rash. In severe cases, dengue can be fatal. Each year, up to 400 million people are infected by a dengue virus. About 100 million people get sick from infection, and 40,000 die from severe dengue, according to the CDC.
Takeda's tetravalent dengue vaccine candidate (TAK-003) is based on a live-attenuated dengue serotype 2 virus. It was being evaluated by the FDA for the prevention of dengue disease in people 4 years through 60 years of age. The regulatory agency had granted priority review to TAK-003 in November 2022.
Takeda’s phase 3 TIDES program included more than 20,000 children and adolescents in eight dengue endemic areas. The vaccine 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. The TIDES exploratory analyses showed that throughout the 4.5-year study follow-up, TAK-003 prevented 61% of symptomatic dengue cases in the overall population, including both seropositive and seronegative individuals.
Last year, TAK-003 received a positive opinion from the Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA) after going through the EU-M4all process, a parallel review of the vaccine for use in the EU and participating dengue endemic countries around the world. The vaccine, with the name QDENGA, has since been approved in the EU, United Kingdom, Brazil, Argentina, Indonesia, and Thailand.