Investor Presentaiton
9
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TM
Qdenga™ Approved in Indonesia & EU for Prevention of Dengue Disease
Dengue letravalent vaccine Against All Serotypes, Regardless of Prior Dengue Exposure
(Live, Attenuated)
Significant prevention of hospitalizations, an important
factor for dengue fever management¹
Pivotal study in >20,000 children and adolescents in Latin America & Asia
• 80.2% reduction in symptomatic dengue @ 12 months (primary endpoint);
90.4% reduction in hospitalizations @18 months (key secondary endpoint)
• Continued protection through 4.5 years (exploratory analyses):
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61% reduction in symptomatic dengue and 84% reduction in hospitalizations
No important safety risks identified²
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Takeda
Two approvals in 2022 and continuing regulatory progress
around the world
First approval in Indonesia in Aug 2022 for individuals 6-45 years of age
Approved in EU in Dec 2022 for individuals 4 years of age and older,
and positive CHMP opinion recommending use in dengue-endemic
countries that participated in the EMA EU-M4all procedure
Regulatory reviews progressing in dengue-endemic countries in Latin
America & Asia
Cumulative Incidence of Participants
With Hospitalised Virologically
Confirmed Dengue, %
2.51
2.0-
1.5-
1.0-
0.5-
84% reduction of
hospitalized cases
0
0 3 69
12 15 18 21 24 27 30 33 36 39 42 45
48
51 54 57
Placebo,
seropositive
Time Since First Vaccination, Months
Placebo,
seronegative
TAK-003,
seropositive
TAK-003,
seronegative
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Granted priority review by U.S. FDA in November 2022
1.Tricou, V. Efficacy and Safety of Takeda's Tetravalent Dengue Vaccine Candidate (TAK-003) After 4.5 Years of Follow-Up.
Presented at the 8th Northern European Conference of Travel Medicine; June 2022.
2. Most common adverse events were injection-site pruritus, bruising, and pyrexia
EMA: European Medicines AgencyView entire presentation