U.S. travelers and healthcare providers looking for another—and potentially safer—dengue vaccine will have to keep waiting.
After a protracted review, Takeda has decided to withdraw the application for its dengue vaccine candidate, TAK-003, from the FDA, the Japanese company said Tuesday.
The decision comes after the FDA sought additional data that were not captured by the phase 3 TIDES trial used for the application, a Takeda spokesperson told Fierce Pharma. The company figured it couldn’t satisfy the agency’s needs within the current review cycle.
Takeda is exploring all options and will need time to fully evaluate the requirements for a resubmission in the U.S., the company spokesperson said.
“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,” Takeda said in a statement.
TAK-003, also known as Qdenga, is already approved in Europe, the U.K., Brazil, Argentina, Indonesia and Thailand. Takeda will continue to seek approvals for Qdenga elsewhere as it works to determine the next steps in the U.S., Gary Dubin, M.D., president of Takeda’s vaccines business unit, said in a statement Tuesday.
Takeda has been counting on the two-dose dengue shot as a growth driver as it deals with costly patent expirations in its pharma portfolio. Targeting launches in 25 countries, Takeda recently updated its peak sales estimate for the vaccine to between $1.6 billion and $2 billion, up from a previous target of $700 million to $1.6 billion. The company has also started making capacity expansions in anticipation of strong demand.
