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Key takeaways:
- Takeda voluntarily withdrew an application to the FDA for its dengue vaccine.
- Another dengue vaccine has been approved in the US since 2019 but is available only to a narrow population.
Takeda’s dengue vaccine candidate is no longer under review for approval in the United States.
The company said it voluntarily withdrew the biologics license application (BLA) for the tetravalent vaccine TAK-003 following discussions with the FDA about data that the agency said were missing from the application.
Takeda has voluntarily withdrawn an application to the FDA for its dengue vaccine. Image: Healio
“The FDA sought additional data not captured within the TAK-003 trial protocol, which was previously reviewed and accepted by the FDA,” a Takeda spokesperson clinical clarified to Healio.
Specifically, the spokesperson said the FDA “characterized some data that were not required per the protocol as missing data.”
“For example, they asked for additional data on participants with fevers who did not require hospitalization during the long-term follow-up phase of the study,” the spokesperson said. “This information was not specified in the protocol and therefore was not available. Takeda and the FDA were unable to agree on a path forward to address this and other related topics within the current BLA review time.”
As of June 1, there have been 129 reported cases of dengue in the US and 256 in US territories, according to the CDC. Three of the US cases — two in Florida and one in Texas — were requested locally by infected mosquitoes. The other cases were associated with travel.
WHO estimates that around half of the world’s population is now at risk for dengue, with 100 to 400 million infections occurring annually.
TAK-003 is already approved in Argentina, Brazil, the European Union, Indonesia, Thailand and the United Kingdom, where it is branded as Qdenga.
A different dengue vaccine, Sanofi Pasteur’s Dengvaxia, has been approved for use in the US since 2019 and recommended by the CDC since 2021 — although only for children aged 9 to 16 years in areas with endemic transmission who have laboratory confirmation of a prior dengue virus infection.
Dengvaxia is not available for children who have not previously had dengue because the vaccine can act as an initial dengue virus infection, making the child more susceptible to a severe case of dengue if they are infected naturally later on.
Infection with one of the four dengue serotypes confers immunity only to that serotype and not to the other three, and a previously infected person’s risk for severe illness is higher if they contract one of the other serotypes.
An ongoing phase 3 trial that enrolled more than 20,000 children in eight countries found that TAK-003 was effective regardless of previous dengue exposure, according to results originally presented at a conference in 2018 and later published in The New England Journal of Medicine.
The Takeda spokesperson said the BLA withdrawal “will not impact the existing approach for TAK-003” and that “the company remains confident in its dengue vaccine.”
“Takeda will continue to progress regulatory filings in countries globally, and the future plan for TAK-003 in the US will be further evaluated given the unmet need for travelers and those living in dengue-endemic areas of the US, such as Puerto Rico, ” the spokesperson said. “The company will communicate any clinical development program updates when they can.”
References:
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