Takeda has withdrawn the biologics licence application (BLA) submitted to the US Food and Drug Administration (FDA) for TAK-003, a tetravalent dengue vaccine candidate.
The vaccine is based on a live-attenuated dengue serotype 2 virus.
This development comes after the company held talks with the regulatory agency on data collection issues that cannot be resolved within the review cycle of this application.
The prospective strategy for the vaccine in the US will be further assessed based on the requirements of travellers as well as those residing in dengue-endemic regions of the country, such as Puerto Rico.
TAK-003’s safety and efficacy were validated in a Phase III clinical trial carried out over 4.5 years in more than 20,000 children and adolescents from eight dengue-endemic regions.
The vaccine received approval in the EU, UK, Thailand, Argentina, Indonesia and Brazil, with further approvals anticipated.
Takeda vaccines business unit president Gary Dubin stated: “Our clinical programme 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.
“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 travelling to dengue-endemic areas while we work to determine next steps in the US.”
The company has also entered a discovery partnership and licence deal with F-star Therapeutics to develop multi-specific antibodies.
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