Takeda withdraws FDA approval application for dengue vaccine

11 Jul 2023
www.biopharmadive.com
VaccineDrug ApprovalClinical ResultClinical Study
Takeda Pharmaceutical said Tuesday it has withdrawn an application for U.S. approval of its dengue vaccine after discussions with the Food and Drug Administration over data collection issues.
According to Takeda, those issues could not be addressed within the regulator’s standard review cycle, so the Japanese drugmaker opted to pull its application instead.
“[W]e 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.,” said Gary Dubin, head of Takeda’s vaccine business unit, in a statement.
According to the World Health Organization, about half of the world’s population is at risk of dengue, a viral disease transmitted via mosquitoes. It’s commonly found in tropical and subtropical climates, and reported cases have increased substantially over the past two decades.
For most people, the disease does not trigger symptoms, or causes mild effects like fever, headache and nausea. But the disease can be more severe in others and, in rare cases, lead to death. There is no specific treatment for dengue.
One other preventive vaccine, from Sanofi, is available in some countries, including the U.S., but use is restricted by age, past infection status and whether individuals live in areas where the disease is endemic.
Takeda’s vaccine was approved last year in the EU, where it is sold as Qdenga for people aged four years and older. It’s also available in the U.K., Brazil, Argentina, Indonesia and Thailand.
The company tested the shot in a 4.5-year clinical trial of over 20,000 children and adolescents who lived in eight dengue endemic areas. Results showed it protected against symptomatic dengue and hospitalization from the disease.
The trial, which consisted of five parts, is ongoing to study vaccine efficacy one year after booster vaccination as well as long-term efficacy and safety.
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