OSAKA, Japan & CAMBRIDGE, Mass. - Saturday, 10. December 2022
− The European Commission Approved QDENGA (TAK-003) for Use in Individuals Four Years of Age and Olderi
− QDENGA Becomes the Only Dengue Vaccine Approved in the EU for Use in Individuals Regardless of Previous Dengue Exposurei
(BUSINESS
WIRE) -- Takeda (TSE:4502/NYSE:TAK) today announced that the European
Commission (EC) granted marketing authorization for the company’s dengue
vaccine QDENGA® (Dengue Tetravalent Vaccine [Live, Attenuated])
(TAK-003) for the prevention of dengue disease in individuals from four
years of age in the European Union (EU).i QDENGA should be used in
accordance with official recommendations. The approval follows the
positive recommendation from the European Medicines Agency’s Committee
for Medicinal Products for Human Use (CHMP) in October 2022.
“With
the increasing ease of travel today, our once expansive world has
become that much smaller, increasing the risk of dengue disease for
those living in dengue-endemic areas and for those traveling to these
regions,” said Gary Dubin, M.D., president of the Global Vaccine
Business Unit at Takeda. “The European Commission's approval marks an
important turning point for QDENGA as we are one step closer to
achieving our aspiration to help reduce the global burden of dengue. We
are proud to introduce QDENGA in many parts of the EU, offering
healthcare providers a new tool in dengue prevention for their patients
living in the EU and traveling to endemic regions around the world.”
The
worldwide incidence of dengue has risen eight-fold in the past 20
years, and it continues to rise, fueled by climate change and
urbanization.ii Today, dengue threatens about half the world’s
population with a risk of infection in over 125 countries, and the
disease is endemic in most of the European overseas countries,
territories and departments located in tropical areas.ii,iii These
factors have led to events of local transmission in non-endemic areas in
continental Europe, including France, Italy, Germany and Spain.iv
Dengue is a leading cause of fever in travelers returning to Europe from
endemic countries, and the incidence of dengue among European travelers
is generally underestimated.v,vi The threat of disease is present for
more than 26 million people from Europe who typically travel to endemic
regions each year for holidays and visiting friends and family.vii
“Effective
dengue prevention requires a multi-faceted approach, and previous
methods have been insufficient for a number of reasons. With the
potential for dengue to cause local outbreaks as demonstrated in several
European countries over recent years, and the threat for European
travelers visiting dengue-endemic countries, gaps exist that may put
some people at risk,” said Dr. Tomas Jelinek, Medical Director of the
Berlin Centre for Travel and Tropical Medicine and Scientific Director
of the CRM Centrum für Reisemedizin Dusseldorf. “As a clinician, it is
encouraging to have a new dengue vaccination tool available for a broad
population of my patients.”
Approval from the EC was supported by
results across 19 Phase 1, 2 and 3 trials with more than 28,000
children and adults, including four and a half years of follow-up data
from the global, pivotal Phase 3 Tetravalent Immunization against Dengue
Efficacy Study (TIDES) trial. The TIDES trial met its primary endpoint
of overall vaccine efficacy (VE) by preventing 80.2% of symptomatic
dengue cases 12 months after vaccination.viii In addition, TAK-003 met
its key secondary endpoint by preventing 90.4% of hospitalizations 18
months after vaccination.ix Efficacy varied by serotype (DENV-1 –
4).viii,ix The TIDES exploratory analyses showed that throughout the
4.5-year study follow-up, TAK-003 prevented 84% of hospitalized dengue
cases and 61% of symptomatic dengue cases in the overall population,
including both seropositive and seronegative individuals.x TAK-003 has
been generally well tolerated, with no evidence of disease enhancement
in vaccine recipients, and no important safety risks have been
identified, to date.x
QDENGA is also approved in Indonesia for
the prevention of dengue disease by any serotype in individuals six
years to 45 years of age. Takeda continues to progress regulatory
filings in other dengue-endemic countries in Asia and Latin America.
The
EC decision has no impact on the full year consolidated reported
forecast for the fiscal year ending March 31, 2023 (Fiscal Year 2022).
About QDENGA
QDENGA
(TAK-003) is a dengue vaccine that is based on a live-attenuated dengue
serotype 2 virus, which provides the genetic “backbone” for all four
dengue virus serotypes and is designed to protect against any of these
serotypes.xi
In the European Union (EU) Member States, QDENGA is
indicated for the prevention of dengue disease in individuals from four
years of age and should be administered subcutaneously as a 0.5 mL dose
at a two-dose (0 and 3 months) schedule pursuant to approved dosing
regimen.i QDENGA should be used in accordance with official
recommendations.
QDENGA was assessed across a clinical
development program that included 19 Phase 1, Phase 2 and Phase 3
trials, and more than 28,000 participants, including Takeda’s pivotal
Tetravalent Immunization against Dengue Efficacy Study (TIDES) trial.
The TIDES trial met its primary endpoint of overall vaccine efficacy
(VE) against virologically-confirmed dengue (VCD) with 80.2% efficacy at
12-months follow-up.viii The trial also met all secondary endpoints for
which there were a sufficient number of dengue cases at 18-months
follow-up.ix The VE result in preventing hospitalization due to VCD
fever was 90.4%.ix Through four and a half years (54 months after the
second dose), QDENGA demonstrated continued overall protection, with
sustained overall VE of 61.2% and 84.1% VE against hospitalized dengue.x
Observations of VE varies by serotype and remained consistent with
previously reported results.x QDENGA has been generally well tolerated,
with no evidence of disease enhancement in vaccine recipients, and no
important safety risks have been identified in the TIDES trial, to
date.x
Important Safety Information
Please consult the Summary of Product Characteristics (SmPC) before prescribing.
Guidance
for use: QDENGA should be administered by subcutaneous injection
preferably in the upper arm in the region of deltoid. QDENGA must not be
injected intravascularly, intradermally or intramuscularly. Vaccination
should be postponed in subjects suffering from an acute severe febrile
illness. The presence of a minor infection, such as a cold, should not
result in a deferral of vaccination. Vaccination should be preceded by a
review of the individual’s medical history (especially with regards to
previous vaccination and possible hypersensitivity reactions which
occurred after vaccination). Appropriate medical treatment and
supervision must always be readily available in the event of a rare
anaphylactic reaction following administration of the vaccine.
Anxiety-related reactions, including vasovagal reactions (syncope),
hyperventilation or stress-related reactions may occur in association
with vaccination as a psychogenic response to the needle injection. It
is important that precautions are in place to avoid injury from
fainting. A protective immune response with Qdenga may not be elicited
in all vaccinees against all serotypes of dengue virus and may decline
over time. It is currently unknown whether a lack of protection could
result in an increased severity of dengue. It is recommended to continue
personal protection measures against mosquito bites after vaccination.
Individuals should seek medical care if they develop dengue symptoms or
dengue warning signs.
Contraindications: Hypersensitivity to the
active substances or excipients listed, or to previous Qdenga dose.
Individuals with congenital or acquired immune deficiency, including
immunosuppressive therapies such as chemotherapy or high doses of
systemic corticosteroids (eg, 20 mg/day or 2 mg/kg body weight/day of
prednisone for 2 weeks or more) within 4 weeks prior to vaccination.
Individuals with symptomatic HIV infection or asymptomatic HIV infection
with impaired immune function. Pregnant and breast-feeding women.
Adverse
Reactions: Most frequently reported reactions in subjects 4 to 60 years
of age were injection site pain (50%), headache (35%), myalgia (31%),
injection site erythema (27%), malaise (24%), asthenia (20%), and fever
(11%). Very common: (≥1/10 of subjects): upper respiratory tract
infectiona, decreased appetitec, irritabilityc, headache, somnolencec,
myalgia, injection site pain, injection site erythema, malaise,
asthenia, fever. Common (≥1/100 to <1/10): nasopharyngitis,
pharyngotonsillitisb, arthralgia, injection site swelling, injection
site bruisinge, injection site prurituse, influenza like illness.
aIncludes upper respiratory tract infection and viral upper respiratory
tract infection. bIncludes pharyngotonsillitis and tonsillitis.
cCollected in children below 6 years of age in clinical studies.
dIncludes rash, viral rash, rash maculopapular, and rash pruritic.
eReported in adults in clinical studies. Refer to the SmPC for details
on full side effect profile and interactions.
▼ This medicinal
product is subject to additional monitoring. This will allow quick
identification of new safety information. Healthcare professionals are
asked to report any suspected adverse reactions. See Section 4.8 of the
SmPC for how to report adverse reactions.
For full prescribing information, please see the Summary of Product Characteristics (SmPC) for QDENGA®▼.
Please consult with your local regulatory agency for any approved labeling in your country.
The
drug information contained herein is intended to disclose corporate
information. Nothing contained in this document should be considered a
solicitation, promotion, or indication for any prescription drug,
including those currently under development.
About Dengue
Dengue
is a mosquito-borne viral disease that spreads rapidly around the world
and was one of the WHO’s top 10 threats to global health in 2019.ii,xii
Dengue is mainly spread by Aedes aegypti mosquitoes and, to a lesser
extent, Aedes albopictus mosquitoes. It is caused by any of four dengue
virus serotypes, each of which can cause dengue fever or severe
dengue.ii The prevalence of individual serotypes varies across different
geographies, countries, regions, seasons and over time.xiii Recovery
from infection by one serotype provides lifelong immunity against only
that serotype, and later exposure to any of the remaining serotypes is
associated with an increased risk of severe disease.ii
About the Phase 3 TIDES (DEN-301) Trial
The
double-blind, randomized, placebo-controlled Phase 3 Tetravalent
Immunization against Dengue Efficacy Study (TIDES) trial is evaluating
the safety and efficacy of two doses of TAK-003 in the prevention of
laboratory-confirmed symptomatic dengue fever of any severity and due to
any of the four dengue virus serotypes in children and adolescents.viii
The TIDES trial is Takeda’s largest interventional clinical trial to
date and enrolled over 20,000 healthy children and adolescents ages four
to 16 years living in dengue-endemic areas.viii Study participants were
randomized 2:1 to receive two doses of TAK-003 0.5 mL or placebo on
Months 0 and 3, administered subcutaneously.viii The study is comprised
of five parts. Part 1 and the primary endpoint analysis evaluated
vaccine efficacy (VE) and safety through 12 months after the second
dose.viii Part 2 continued for an additional six months to complete the
assessment of the secondary endpoints of VE by serotype, baseline
serostatus and disease severity, including VE against hospitalized
dengue.ix Part 3 evaluated VE and long-term safety by following
participants for an additional two and a half to three years, as per WHO
recommendations.xiv Part 4 will evaluate efficacy and safety for 13
months following booster vaccination and Part 5 will evaluate long-term
efficacy and safety for one year after completion of Part 4.xiv
The
trial is taking place at sites in dengue-endemic areas in Latin America
(Brazil, Colombia, Panama, the Dominican Republic and Nicaragua) and
Asia (Philippines, Thailand and Sri Lanka) where there are unmet needs
in dengue prevention and where severe dengue is a leading cause of
serious illness and death among children.xiv Baseline blood samples were
collected from all individuals participating in the trial to allow for
evaluation of safety and efficacy based on serostatus. Takeda and an
independent Data Monitoring Committee of experts are actively monitoring
safety on an ongoing basis.
Takeda’s Commitment to Vaccines
Vaccines
prevent 3.5 to 5 million deaths each year and have transformed global
public health.xv For more than 70 years, Takeda has supplied vaccines to
protect the health of people in Japan. Today, Takeda’s global vaccine
business is applying innovation to tackle some of the world’s most
challenging infectious diseases, such as dengue, COVID-19, pandemic flu
and Zika. Takeda’s team brings an outstanding track record and a wealth
of knowledge in vaccine development and manufacturing to advance a
pipeline of vaccines to address some of the world’s most pressing public
health needs. For more information, visit
www.Takeda.com/what-we-do/areas-of-focus/vaccines/.
About Takeda
Takeda
is a global, values-based, R&D-driven biopharmaceutical leader
headquartered in Japan, committed to discover and deliver
life-transforming treatments, guided by our commitment to patients, our
people and the planet. Takeda focuses its R&D efforts on four
therapeutic areas: Oncology, Rare Genetics and Hematology, Neuroscience,
and Gastroenterology (GI). We also make targeted R&D investments in
Plasma-Derived Therapies and Vaccines. We are focusing on developing
highly innovative medicines that contribute to making a difference in
people’s lives by advancing the frontier of new treatment options and
leveraging our enhanced collaborative R&D engine and capabilities to
create a robust, modality-diverse pipeline. Our employees are committed
to improving quality of life for patients and to working with our
partners in health care in approximately 80 countries and regions. For
more information, visit https://www.takeda.com.
Important Notice
For
the purposes of this notice, “press release” means this document, any
oral presentation, any question and answer session and any written or
oral material discussed or distributed by Takeda Pharmaceutical Company
Limited (“Takeda”) regarding this release. This press release (including
any oral briefing and any question-and-answer in connection with it) is
not intended to, and does not constitute, represent or form part of any
offer, invitation or solicitation of any offer to purchase, otherwise
acquire, subscribe for, exchange, sell or otherwise dispose of, any
securities or the solicitation of any vote or approval in any
jurisdiction. No shares or other securities are being offered to the
public by means of this press release. No offering of securities shall
be made in the United States except pursuant to registration under the
U.S. Securities Act of 1933, as amended, or an exemption therefrom. This
press release is being given (together with any further information
which may be provided to the recipient) on the condition that it is for
use by the recipient for information purposes only (and not for the
evaluation of any investment, acquisition, disposal or any other
transaction). Any failure to comply with these restrictions may
constitute a violation of applicable securities laws.
The
companies in which Takeda directly and indirectly owns investments are
separate entities. In this press release, “Takeda” is sometimes used for
convenience where references are made to Takeda and its subsidiaries in
general. Likewise, the words “we”, “us” and “our” are also used to
refer to subsidiaries in general or to those who work for them. These
expressions are also used where no useful purpose is served by
identifying the particular company or companies.
Forward-Looking Statements
This
press release and any materials distributed in connection with this
press release may contain forward-looking statements, beliefs or
opinions regarding Takeda’s future business, future position and results
of operations, including estimates, forecasts, targets and plans for
Takeda. Without limitation, forward-looking statements often include
words such as “targets”, “plans”, “believes”, “hopes”, “continues”,
“expects”, “aims”, “intends”, “ensures”, “will”, “may”, “should”,
“would”, “could” “anticipates”, “estimates”, “projects” or similar
expressions or the negative thereof. These forward-looking statements
are based on assumptions about many important factors, including the
following, which could cause actual results to differ materially from
those expressed or implied by the forward-looking statements: the
economic circumstances surrounding Takeda’s global business, including
general economic conditions in Japan and the United States; competitive
pressures and developments; changes to applicable laws and regulations,
including global health care reforms; challenges inherent in new product
development, including uncertainty of clinical success and decisions of
regulatory authorities and the timing thereof; uncertainty of
commercial success for new and existing products; manufacturing
difficulties or delays; fluctuations in interest and currency exchange
rates; claims or concerns regarding the safety or efficacy of marketed
products or product candidates; the impact of health crises, like the
novel coronavirus pandemic, on Takeda and its customers and suppliers,
including foreign governments in countries in which Takeda operates, or
on other facets of its business; the timing and impact of post-merger
integration efforts with acquired companies; the ability to divest
assets that are not core to Takeda’s operations and the timing of any
such divestment(s); and other factors identified in Takeda’s most recent
Annual Report on Form 20-F and Takeda’s other reports filed with the
U.S. Securities and Exchange Commission, available on Takeda’s website
at: https://www.takeda.com/investors/sec-filings/ or at www.sec.gov.
Takeda does not undertake to update any of the forward-looking
statements contained in this press release or any other forward-looking
statements it may make, except as required by law or stock exchange
rule. Past performance is not an indicator of future results and the
results or statements of Takeda in this press release may not be
indicative of, and are not an estimate, forecast, guarantee or
projection of Takeda’s future results.
Medical information
This
press release contains information about products that may not be
available in all countries, or may be available under different
trademarks, for different indications, in different dosages, or in
different strengths. Nothing contained herein should be considered a
solicitation, promotion or advertisement for any prescription drugs
including the ones under development.
_______________________________
i Takeda. QDENGA Summary of Product Characteristics. Retrieved December 2022.
ii World Health Organization. Dengue and Severe Dengue. January 2022. Retrieved December 2022.
iii European Centre for Disease Prevention and Control (ECDC). Factsheet about dengue. November 2021. Retrieved December 2022.
iv
European Centre for Disease Prevention and Control (ECDC).
Autochthonous transmission of dengue virus in EU/EEA, 2010-present.
October 2022. Retrieved December 2022.
v Bulugahapitiya, U.,
Siyambalapitiya, S., Seneviratne, S. L., & Fernando, D. J. (2007).
Dengue fever in travellers: A challenge for European physicians.
European journal of internal medicine, 18(3), 185–192.
https://doi.org/10.1016/j.ejim.2006.12.002
vi T. Jelinek, N.
Mühlberger, G. Harms, et al. European Network on Surveillance of
Imported Infectious Diseases, Epidemiology and Clinical Features of
Imported Dengue Fever in Europe: Sentinel Surveillance Data from
TropNetEurop, Clin Inf Dis. Volume 35, Issue 9, 1 November 2002, Pages
1047–1052, https://doi.org/10.1086/342906
vii Travel data from: UNWTO. Yearbook of Tourism Statistics, Data 2014-2018. 2020.
viii
Biswal S, et al. Efficacy of a tetravalent dengue vaccine in healthy
children and adolescents. N Engl J Med. 2019; 2019;381:2009-2019.
ix
Biswal S, et al. Efficacy of a tetravalent dengue vaccine in healthy
children aged 4-16 years: a randomized, placebo controlled, phase 3
trial. Lancet. 2020. 2020;395:1423-1433.
x 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.
xi Huang CY-H, et al.
Genetic and phenotypic characterization of manufacturing seeds for
tetravalent dengue vaccine (DENVax). PLoS Negl Trop Dis. 2013;7:e2243.
xii World Health Organization. Ten threats to global health in 2019. January 2019. December 2022.
xiii Guzman MG, et al. Dengue: a continuing global threat. Nature Reviews Microbiology. 2010;8:S7-S16.
xiv
Efficacy, Safety and Immunogenicity of Takeda’s Tetravalent Dengue
Vaccine (TDV) in Healthy Children (TIDES). Retrieved December 2022.
xv World Health Organization. Vaccines and immunization. October 2022. Retrieved December 2022.
View source version on businesswire.com: https://www.businesswire.com/news/home/20221208005204/en/
Permalink
https://www.aetoswire.com/en/news/1012202229011
Contacts
Media:
Japanese Media
Jun Saito
jun.saito@takeda.com
+81 (0) 3-3278-2325
U.S. and International Media
Rachel Higgins
rachel.higgins@takeda.com
+1 917-796-8703
No comments:
Post a Comment