Takeda voluntary withdraws US Biologics License Application for Dengue vaccine
Takeda's tetravalent dengue vaccine candidate (TAK-003) is based on a live-attenuated dengue serotype 2 virus, which provides the genetic "backbone" for all four vaccine viruses.
Osaka: Takeda has announced that the Company has voluntarily withdrawn the U.S. Biologics License Application (BLA) for its dengue vaccine candidate, TAK-003, following discussions with the U.S. Food and Drug Administration (FDA) on aspects of data collection, which cannot be addressed within the current BLA review cycle.
The future plan for TAK-003 in the U.S. will be further evaluated given the need for travelers and those living in dengue-endemic areas of the U.S., such as Puerto Rico. The vaccine is approved in multiple endemic and non-endemic countries, with more approvals expected over the coming years.
“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,” said Gary Dubin, M.D., president of Takeda’s Vaccines Business Unit. “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.”
The efficacy and safety profiles of TAK-003 have been demonstrated through a robust clinical trial program, including a 4.5-year Phase 3 study of over 20,000 children and adolescents living in eight dengue endemic areas. The study was designed per World Health Organization (WHO) guidance for a second-generation dengue vaccine, and it considered the need to achieve high levels of subject retention and protocol compliance in endemic regions.
Last year, TAK-003 received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) 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 has since been approved in the EU, United Kingdom, Brazil, Argentina, Indonesia, and Thailand.
Dengue is a global public health crisis and further prevention measures are needed to support the millions of individuals around the world exposed to dengue.
Takeda's tetravalent dengue vaccine candidate (TAK-003) is based on a live-attenuated dengue serotype 2 virus, which provides the genetic “backbone” for all four vaccine viruses.
