Japanese pharma company Takeda has announced long-term safety and efficacy results for its dengue vaccine candidate, TAK-003, and has successfully submitted filing packages with the EMA, intending to submit further filings in nine other countries in 2021.
In the Phase III Tetravalent Immunization against Dengue Efficacy Study (TIDES) trial, TAK-003 demonstrated continued protection against dengue illness and hospitalisation, regardless of an individual’s previous dengue exposure, with no important safety risks identified through three years after vaccination.
The TIDES trial enrolled more than 20,000 healthy children and adolescents ages four to 16 years in dengue-endemic countries in Latin America and Asia, and 36-month follow-up exploratory analysis was presented at the 17th Conference of the International Society of Travel Medicine this month.
Through three years, TAK-003 demonstrated overall vaccine efficacy (VE) of 62.0% against virologically-confirmed dengue (VCD), with 65.0% VE in seropositive individuals and 54.3% VE in seronegative individuals. TAK-003 also demonstrated 83.6% VE against hospitalised dengue, with 86.0% VE in seropositive individuals and 77.1% VE in seronegative individuals.
LakKumar Fernandoi, from the Center for Clinical Management of Dengue and Dengue Haemorrhagic Fever, Negombo General Hospital, Sri Lanka and a primary investigator of the TIDES trial, said: “Dengue epidemics occur suddenly, and hospitals can become overwhelmed with severe disease cases and people seeking testing.
“Results from the long-term analysis of Takeda’s dengue vaccine candidate suggest that it could help with outbreak prevention, reduce rates of hospitalisation, and protect people from dengue regardless of their previous exposure. Importantly, no important safety risks were identified.”
As previously reported, the TIDES trial met its primary endpoint of overall VE against VCD at 12-months follow-up and all secondary endpoints for which there were a sufficient number of dengue cases (measured at 18-months follow-up).
TIDES safety and efficacy data through 36-months follow-up was included in regulatory submissions to the European Union and dengue-endemic countries and will be part of additional filings planned for 2021, including in the United States.
Takeda will seek an indication for TAK-003 for the prevention of dengue disease in individuals four to 60 years of age, regardless of previous virus exposure, based on data in both adults and children.
Takeda intends to submit regulatory filings in Argentina, Brazil, Colombia, Indonesia, Malaysia, Mexico, Singapore, Sri Lanka and Thailand during 2021.
Derek Wallace, VP and Dengue Global Programme Leader at Takeda, said: “Our dengue vaccine candidate continued to provide protection against dengue throughout three years, and was especially robust in preventing hospitalisation. These results reinforce my confidence that TAK-003 can help address the significant global burden of dengue.”
Kat Jenkins
This is a syndicated feed from Pharmafile
