- Committee for Medicinal Products for Human Use of the European Medicines Agency recommended permission Takeda Pharmaceutical Co.Ltd TAK Dengue vaccine candidate, TAK-003.
- In August, Indonesia approved Takeda’s dengue vaccine, Qdenga, for People between the ages of six and 45.
- The recommendation relates to the dengue vaccine candidate for the prevention of dengue disease caused by any serotype in individuals four years of age and older in Europe and dengue-endemic countries.
- The committee’s positive opinion was supported by results from five phase 1, 2 and 3 studies involving over 28,000 participants.
- This includes four and a half years of follow-up data from the global, pivotal phase 3 TIDES study, which is in line with the World Health Organization’s recommendation for three to five years of follow-up data after completion of a primary dengue vaccination to determine the Assess safety and effectiveness accurately.
- TIDES’ exploratory analyzes showed that TAK-003 prevented 84% of in-hospital dengue cases and 61% of symptomatic dengue cases in the general population over the four and a half years of study follow-up.
- TAK-003 was generally well tolerated with no evidence of disease exacerbation in vaccinated recipients.
- Price promotion: TAK shares are up 0.31% to $12.92 on the latest check Friday.
- Photo of Himas Rafeek out Pixabay
