Dengue vaccine! Qdenga (TAK-003, live attenuated quadrivalent vaccine) enters priority review in the United States!

Nov.
22, 2022 /Biovalley BIOON/ -- Takeda Pharmaceuticals (Takeda) today announced that the U.
S.
Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for TAK-003 (Dengue Quadrivalent Vaccine [Live Attenuated Vaccine]) for priority review for use in people aged 4 to 60 years to prevent dengue disease
caused by any dengue virus serotype.

Dengue is a mosquito-borne virus endemic to more than 125 countries around the world, including the U.
S.
overseas territory of Puerto Rico, the U.
S.
Virgin Islands and American Samoa
.
Over the past two decades, the incidence of dengue has increased globally and is the leading cause
of fever among travelers returning from Latin America, the Caribbean and Southeast Asia.

In October this year, TAK-003 received good news
in the EU regulatory area.
The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive review recommending approval of TAK-003: Prevention of dengue disease
caused by any dengue virus serotype in people aged 4 years and older in the EU and dengue-endemic countries participating in the parallel EU-M4all procedure.
Takeda expects TAK-003 to receive approval from the EU EMA in the coming months, followed by regulatory approval decisions
in Latin America and Asia.

In August 2022, Qdenga (TAK-003) was approved by Indonesia's National Agency for Drug and Food Control (BADAN POM) for use in people aged 6 to 45 years to prevent dengue disease
caused by any serotype.
Qdenga can be used by everyone, regardless of previous history of dengue exposure, and does not require pre-vaccination testing
.
The Qdenga vaccination schedule is: 2 doses (0 months, 3 months) subcutaneously at
a dose of 0.
5 mL.

TAK-003 is a live attenuated dengue quadrivalent vaccine developed based on attenuated dengue serotype 2 virus (DENV-2), which provides the genetic backbone
against all 4 vaccine viruses.
Data from the Phase 2 clinical study in children and adolescents showed that TAK-003 induced neutralizing antibodies against four serotypes of dengue virus across all age groups and in both serr-positive and serr-negative individuals, while the vaccine was safe and well tolerated
.

TAK-003 BLA is supported by 4.
5-year follow-up data from the pivotal Phase 3 TIDES trial worldwide, which is in line with the World Health Organization's (WHO) recommendation to obtain follow-up data 3-5 years after completion of dengue vaccination in order to most accurately assess safety and efficacy
.
The trial met the primary endpoint: TAK-003 prevented 80.
2% of symptomatic dengue cases
at 12 months after the second dose.
In addition, the trial met a secondary endpoint: TAK-003 prevented 90.
4% of hospitalizations
at 18 months after the second dose.

An exploratory analysis of the TIDES trial showed that after 4.
5 years of study follow-up (54 months after the second dose): in the general population (including seropositive and seronegative individuals), TAK-003 showed sustained overall protection, preventing 84% of hospitalized dengue cases and 61% of symptomatic dengue cases
.
To date, TAK-003 has been generally well tolerated, there is no evidence of disease enhancement in vaccinated individuals, and no significant safety risks
have been identified in TIDES trials.

Gary Dubin, President, Takeda's Global Vaccines Group, said, "If approved, we believe TAK-003 has the potential to become an important dengue prevention option
for healthcare providers.
This year, 96% of the 888 dengue infections in the United States were due to travel to dengue-endemic areas
.
Of the 316 dengue infections in endemic areas of the United States, 97% were
locally transmitted.
We are fully committed to working with the U.
S.
FDA to advance the review
of TAK-003.
”

Dengvaxia: The world's first dengue vaccine, produced by Sanofi

Dengue, also known as "breakbone fever," is a mosquito-borne viral disease that spreads rapidly around the world and is one of
the World Health Organization's (WHO) Top 10 Global Health Threats in 2019.
Dengue fever is mainly transmitted by Aedes aegypti mosquitoes, followed by Aedes
albopictus.
It is caused by any of the 4 dengue virus serotypes, each of which can cause dengue or severe dengue
.
The prevalence of each serotype varies
by geography, country, region, season, and over time.
After recovering from an infection with one serotype, you have lifelong immunity to that serotype, and later exposure to any other serotype increases the risk of
severe disease.

The incidence of dengue fever has risen dramatically around the world in recent decades, causing an estimated 390 million infections and 500,000 hospitalizations
each year.
The increase in cases can be attributed to factors such as urbanization, globalization and climate change
.
Severe dengue accounts for approximately 5% of dengue cases and is the leading cause
of severe illness and death in children and adults in Latin America and Asia.

Dengvaxia (CYD-TDV) is a 20-year development of Sanofi's vaccine approved by Mexico in December 2015, becoming the first dengue vaccine approved worldwide
.
Since then, the vaccine has been approved by several dengue-endemic countries in Latin America, Asia, and the European Union in
December 2018.
In the United States, Dengvaxia received FDA approval in May 2019, becoming the first medical preventive tool
for dengue in the US market.

However, more than a year after its launch, according to new safety data from clinical trials published by Sanofi, Dengvaxia can work as expected for people who have been exposed to the dengue virus, but for people who have not been previously infected with dengue, the use of the vaccine may cause severe illness
.
The World Health Organization (WHO) has also made timely recommendations on the scope of use of Dengvaxia, based on ongoing follow-up data: testing should be performed before using Dengvaxia to assess whether vaccinated people have been infected with dengue virus
.

The global health community has been eager for a dengue vaccine
that does not require pre-vaccination testing.
Takeda's strong clinical data indicate that TAK-003 has the potential to be a dengue vaccine to meet this need: it does not require pre-vaccination testing of individuals and is effective in helping to prevent dengue cases and hospitalizations, which will reduce the burden
on dengue-endemic countries, communities and health systems.
(Biovalley Bioon.
com)

Takeda's Biologics License Application (BLA) for Dengue Vaccine Candidate (TAK-003) Granted Priority Review by U.
S.
Food and Drug Administration

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