Travelers and medical professionals from the U.S. who are hoping for a different, maybe safer, dengue vaccination will have to wait.
Takeda has chosen to withdraw its TAK-003 dengue vaccine candidate’s FDA request after a concerning delay, the Japanese firm announced on Tuesday.
Takeda discovered that it couldn’t meet the FDA’s requirements during the current review cycle after speaking with the agency about the elements of data collection. “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 company stated.
It is already legal to use TAK-003, commonly known as Qdenga, in Europe, the U.K., Brazil, Indonesia, Argentina and Thailand. While it contemplates the subsequent steps in the U.S., Takeda is going to keep trying to seek approvals for Qdenga in other countries. This is what the head of Takeda’s vaccines division, Gary Dubin, M.D., declared in a statement on Tuesday.
As it struggles with expensive patent expirations in its pharmaceutical portfolio, Takeda has been relying on the two-dose dengue vaccine as a growth engine. The firm recently revised its peak sales projection for the vaccination from its original aim of $700 million to $1.6 billion to between $1.6 billion and $2 billion, with launches planned for 25 countries. In preparation for high demand, the company even began to make capacity extensions.
The vaccine is meant to replace Sanofi’s scandal-plagued Dengvaxia, whose usage has been limited to children aged 6 to 16 who have a history of dengue illnesses and reside in endemic regions due to safety concerns. In contrast, Qdenga hasn’t demonstrated the severe multiplication of dengue in those who haven’t already contracted the virus.
In November, the FDA assigned Qdenga’s application to an expedited review, which ought to have taken less than six months to conclude as opposed to a conventional review’s 10 months.
The manner in which Takeda gathered the phase 3 study data appears to have raised concerns for the regulator. The majority of FDA-approved medications and vaccines undergo clinical trials in the U.S. and Europe, where clinical trial processes are well-established. The phase 3 TIDES study, which was utilized for Qdenga’s application, was conducted in a number of less developed, dengue-endemic areas in Southeast Asia and Latin America.
Dubin remarked in a statement that the study was developed to take into consideration the dengue virus’ complicated worldwide nature. He continued that the study took into account what was required to attain a high degree of subject retention and compliance with protocols in endemic locations when it was constructed in accordance with World Health Organization (WHO) recommendations for a second-generation dengue vaccination.
After nearly 5 years, Qdenga averted almost 85% of hospital admissions and over 60% of symptomatic dengue disease, according to a long-term exploratory evaluation of the TIDES study. The vaccination was approximately 80% successful versus virologically proven cases of dengue at 12 months in the initial primary investigation.
