Takeda’s QDENGA®? (Dengue Tetravalent Vaccine [Live, Attenuated]) Approved in Indonesia for Use Regardless of Prior Dengue Exposure

• ​Indonesia National Agency for Drug and Food Control, BPOM, Approved QDENGA(TAK-003) for Use in Individuals Six Years to 45 Years of Age1
• QDENGAis the Only Dengue Vaccine Approved in Indonesia for Use in Individuals Without Need for Pre-vaccination Testing
• Indonesia Approval Marks the First for QDENGA, Takeda’s First Marketed Vaccine Outside of Japan

Takeda (TSE:4502/NYSE:TAK) right now introduced the corporate’s dengue vaccine, QDENGA® (Dengue Tetravalent Vaccine [Live, Attenuated]) (TAK-003), was accredited by the Indonesia National Agency for Drug and Food Control, Badan Pengawas Obat dan Makanan (BPOM), for the prevention of dengue illness attributable to any serotype in people six years to 45 years of age. The use of QDENGA must be in accordance with official suggestions. QDENGA is the one dengue vaccine accredited in Indonesia for use in people regardless of earlier dengue publicity and with out the necessity for pre-vaccination testing.¹

“Dengue can affect anyone living in or traveling to endemic areas – regardless of age, health and socio-economic circumstances,” stated Gary Dubin, president of Takeda’s Vaccine Business Unit. “Developing this innovative dengue vaccine has been an exciting challenge, and its approval in Indonesia is an important achievement for Takeda and for public health. We’re proud to introduce QDENGA as a new dengue prevention tool to the people of Indonesia, and we will continue to work with additional regulatory agencies to make QDENGA available globally.”

Dengue is a mosquito-borne viral illness that poses a major world public well being risk, with prevalence in over 125 nations.² In latest years, Indonesia has skilled nearly half of the dengue illness burden inside Southeast Asia and continues to undergo from one of the best burdens of dengue in the world.^3,4 In the primary half of 2022 alone, Indonesia reported over 63,000 dengue circumstances and practically 600 deaths unfold throughout 455 cities in 34 provinces.⁵

“As a doctor, I have seen firsthand the burden dengue disease places on the patients and communities I serve in Indonesia. There is an ongoing fear of an outbreak and contracting the disease, experiencing the physical setbacks dengue can cause as well as the potential financial impacts,” stated Dr. Anggraini Alam, Sp.A(Ok), pediatric infectious illness marketing consultant. “Vaccination will offer health care providers in Indonesia a welcomed advancement in dengue prevention, along with vector control, allowing us to reduce the burden of dengue and protect the broader population.”

The approval of QDENGA is predicated on outcomes by means of three years after vaccination from the continuing Phase 3 Tetravalent Immunization in opposition to Dengue Efficacy Study (TIDES) trial that enrolled over 20,000 wholesome kids and adolescents ages 4 to 16 years residing in dengue-endemic areas in Asia and Latin America. QDENGA demonstrated continued general safety in opposition to dengue sickness and hospitalization three years after vaccination, regardless of a person’s earlier dengue publicity.¹ QDENGA has been usually effectively tolerated, with no vital security dangers recognized in the TIDES trial, so far.⁶ Takeda just lately offered long-term security and efficacy outcomes from the TIDES trial by means of 54 months of follow-up, which additional validated the vaccine’s efficacy and security profile.

Takeda is proud to make QDENGA out there to well being care suppliers and their eligible sufferers in Indonesia and to work with BPOM and native well being consultants to make the vaccine accessible in the approaching months. QDENGA is at present present process regulatory evaluation for the prevention of dengue in kids and adults in the European Union (EU) and in dengue-endemic nations outdoors the EU by means of the EU-M4all (beforehand Article 58) process. It just isn’t accredited for use in different nations.

About QDENGA® ▼ (Dengue Tetravalent Vaccine [Live, Attenuated])

QDENGA® (TAK-003) is a dengue vaccine that’s based mostly on a live-attenuated dengue serotype 2 virus, which offers the genetic “backbone” for all 4 dengue virus serotypes and is designed to guard in opposition to any of these serotypes.⁷

In Indonesia, QDENGA is indicated for the prevention of dengue illness attributable to any dengue virus serotype in people six years to 45 years of age and must be administered subcutaneously as a 0.5 mL dose at a two-dose (0 and three months) schedule pursuant to accredited dosing routine.¹ The use of QDENGA must be in accordance with official suggestions.

QDENGA was assessed throughout a sturdy scientific improvement program that included varied Phase 1, Phase 2 and Phase 3 trials, and greater than 28,000 contributors, together with Takeda’s pivotal Tetravalent Immunization in opposition to Dengue Efficacy Study (TIDES) trial. The TIDES trial met its major endpoint of general vaccine efficacy (VE) in opposition to virologically-confirmed dengue (VCD) with 80.2% efficacy at 12-months follow-up. The trial additionally met all secondary endpoints for which there have been a enough quantity of dengue circumstances at 18-months follow-up.^8,9 The VE outcome in stopping hospitalization as a consequence of VCD fever was 90.4%. Up to a few years after the second dose, VE in stopping VCD was proven for all 4 serotypes in baseline dengue seropositive topics. In baseline seronegative topics, VE was proven for DENV-1 and DENV-2, however not proven for DENV-3 and couldn’t be proven for DENV-4 as a consequence of decrease incidence of circumstances.¹ Through 4 and a half years (54 months after the second dose), QDENGA demonstrated continued general safety, with sustained general VE of 61.2% and 84.1% VE in opposition to hospitalized dengue.⁶

QDENGA has been usually effectively tolerated, with no proof of illness enhancement in vaccine recipients, and no vital security dangers have been recognized in the TIDES trial, so far.⁶

Important Safety Information

Please seek the advice of the Summary of Product Characteristics (SmPC) earlier than prescribing.

Guidance for use: QDENGA must be administered by subcutaneous injection ideally in the higher arm in the area of deltoid. QDENGA should not be injected intravascularly, intradermally or intramuscularly. Vaccination must be postponed in topics affected by an acute extreme febrile sickness. The presence of a minor an infection, akin to a chilly, mustn’t outcome in a deferral of vaccination. Vaccination must be preceded by a evaluation of the person’s medical historical past (particularly close to earlier vaccination and attainable hypersensitivity reactions which occurred after vaccination). Appropriate medical remedy and supervision should at all times be available in the occasion of a uncommon anaphylactic response following administration of the vaccine. Anxiety-related reactions, together with vasovagal reactions (syncope), hyperventilation or stress‐associated reactions could happen in affiliation with vaccination as a psychogenic response to the needle injection. It is vital that precautions are in place to keep away from damage from fainting. A protecting immune response with QDENGA will not be elicited in all vaccinees in opposition to all serotypes of dengue virus and will decline over time. It is at present unknown whether or not a scarcity of safety might outcome in an elevated severity of dengue. It is beneficial to proceed private safety measures in opposition to mosquito bites after vaccination. Individuals ought to search medical care in the event that they develop dengue signs or dengue warning indicators.

Contraindications: Hypersensitivity to the lively substances or excipients listed, or to earlier QDENGA dose. Individuals with congenital or acquired immune deficiency, together with immunosuppressive therapies akin to chemotherapy or excessive doses of systemic corticosteroids (eg, 20 mg/day or 2 mg/kg physique weight/day of prednisone for 2 weeks or extra) inside 4 weeks previous to vaccination. Individuals with symptomatic HIV an infection or asymptomatic HIV an infection with impaired immune perform. Pregnant and breast-feeding girls.

Adverse Reactions: Most ceaselessly reported reactions in topics 4 to 60 years of age had been injection web site ache (50%), headache (35%), myalgia (31%), injection web site erythema (27%), malaise (24%), asthenia (20%), and fever (11%). Very frequent: (≥1/10 of topics): higher respiratory tract an infection^a, decreased urge for food^c, irritability^c, headache, somnolence^c, myalgia, injection web site ache, injection web site erythema, malaise, asthenia, fever. Common (≥1/100 to <1/10): nasopharyngitis, pharyngotonsillitis^b, injection web site swelling, injection web site bruising^e, injection web site pruritus^e, influenza like sickness. ^aIncludes higher respiratory tract an infection and viral higher respiratory tract an infection. ^bIncludes pharyngotonsillitis and tonsillitis. ^cCollected in kids 4-6 years of age in scientific research. ^dIncludes rash, viral rash, rash maculopapular, and rash pruritic. ^eReported in adults in scientific research. Refer to the SmPC for particulars on full aspect impact profile and interactions.

For full prescribing data, please see the Summary of Product Characteristics (SmPC) for QDENGA®▼.

Please seek the advice of along with your native regulatory company for accredited labeling in your nation.

The drug data contained herein is meant to reveal company data. Nothing contained in this doc must be thought of a solicitation, promotion, or indication for any prescription drug, together with these at present beneath improvement.

About EU-M4all¹⁰

EU-M4all (or EU-Medicines for all) is a process designed to facilitate affected person entry to important medicines or vaccines supposed to forestall or deal with ailments of main public well being curiosity. Through the EU-M4all process (beforehand often called the Article 58 process), the EMA, in cooperation with the World Health Organization (WHO), can present scientific opinion on medicines and vaccines for public well being precedence ailments which can be supposed for markets outdoors of the EU.

About the Phase 3 TIDES (DEN-301) Trial

The double-blind, randomized, placebo-controlled Phase 3 Tetravalent Immunization in opposition to Dengue Efficacy Study (TIDES) trial is evaluating the protection and efficacy of two doses of TAK-003 in the prevention of laboratory-confirmed symptomatic dengue fever of any severity and as a consequence of any of the 4 dengue virus serotypes in kids and adolescents.⁸ Study contributors had been randomized 2:1 to obtain two doses of TAK-003 0.5 mL or placebo on Months 0 and three, administered subcutaneously.⁸ The examine is comprised of 5 components. Part 1 and the first endpoint evaluation evaluated vaccine efficacy (VE) and security by means of 12 months after the second dose.⁸ Part 2 continued for a further six months to finish the evaluation of the secondary endpoints of VE by serotype, baseline serostatus and illness severity, together with VE in opposition to hospitalized dengue.⁸ Part 3 evaluated VE and long-term security by following contributors for a further two and a half to a few years, as per World Health Organization (WHO) suggestions.¹¹ Part 4 will consider efficacy and security for 13 months following booster vaccination, and Part 5 will consider long-term efficacy and security for one 12 months after completion of Part 4.¹¹

The trial is happening at websites in dengue-endemic areas in Latin America (Brazil, Colombia, Panama, the Dominican Republic and Nicaragua) and Asia (Philippines, Thailand and Sri Lanka) the place there are unmet wants in dengue prevention and the place extreme dengue is a number one trigger of critical sickness and loss of life amongst kids.¹¹ Baseline blood samples had been collected from all people collaborating in the trial to permit for analysis of security and efficacy based mostly on serostatus. Takeda and an unbiased Data Monitoring Committee of consultants are actively monitoring security on an ongoing foundation.

About Dengue

Dengue is a mosquito-borne viral illness that spreads quickly world wide and was one of the WHO’s prime 10 threats to world well being in 2019.^2,12 Dengue is especially unfold by Aedes aegypti mosquitoes and, to a lesser extent, Aedes albopictus mosquitoes. It is attributable to any of 4 dengue virus serotypes, every of which may trigger dengue fever or extreme dengue. The prevalence of particular person serotypes varies throughout totally different geographies, nations, areas, seasons and over time.¹³ Recovery from an infection by one serotype offers lifelong immunity in opposition to solely that serotype, and later publicity to any of the remaining serotypes could be related to an elevated danger of extreme illness.²

Dengue is pandemic inclined, and outbreaks are noticed in tropical and sub-tropical areas and have just lately triggered outbreaks in components of the continental United States and Europe.^14,15 Approximately half of the world now lives beneath the risk of dengue, which is estimated to trigger 390 million infections and round 20,000 deaths globally annually.^2,13,16 The dengue virus can infect individuals of all ages and is a number one trigger of critical sickness amongst kids in some nations in Latin America and Asia.¹³

Takeda’s Commitment to Vaccines

Vaccines forestall 3.5 to five million deaths annually and have reworked world public well being.¹⁷ For greater than 70 years, Takeda has provided vaccines to guard the well being of individuals in Japan. Today, Takeda’s world vaccine business is making use of innovation to deal with some of the world’s most difficult infectious ailments, akin to dengue, COVID-19, pandemic flu and Zika. Takeda’s staff brings an excellent monitor file and a wealth of data in vaccine improvement and manufacturing to advance a pipeline of vaccines to deal with some of the world’s most urgent public well being wants. For extra data, go to www.Takeda.com/what-we-do/areas-of-focus/vaccines/.

About Takeda

Takeda is a worldwide, values-based, R&D-driven biopharmaceutical chief headquartered in Japan, dedicated to find and ship life-transforming therapies, guided by our dedication to sufferers, our individuals and the planet. Takeda focuses its R&D efforts on 4 therapeutic areas: Oncology, Rare Genetics and Hematology, Neuroscience, and Gastroenterology (GI). We additionally make focused R&D investments in Plasma-Derived Therapies and Vaccines. We are specializing in creating extremely revolutionary medicines that contribute to creating a distinction in individuals’s lives by advancing the frontier of new remedy choices and leveraging our enhanced collaborative R&D engine and capabilities to create a sturdy, modality-diverse pipeline. Our workers are dedicated to enhancing high quality of life for sufferers and to working with our companions in well being care in roughly 80 nations and areas. For extra data, go to https://www.takeda.com.

Important Notice

For the needs of this discover, “press release” means this doc, any oral presentation, any query and reply session and any written or oral materials mentioned or distributed by Takeda Pharmaceutical Company Limited (“Takeda”) concerning this launch. This press launch (together with any oral briefing and any question-and-answer in reference to it) just isn’t supposed to, and doesn’t represent, characterize or type half of any supply, invitation or solicitation of any supply to buy, in any other case purchase, subscribe for, trade, promote or in any other case dispose of, any securities or the solicitation of any vote or approval in any jurisdiction. No shares or different securities are being supplied to the general public by means of this press launch. No providing of securities shall be made in the United States besides pursuant to registration beneath the U.S. Securities Act of 1933, as amended, or an exemption therefrom. This press launch is being given (along with any additional data which can be offered to the recipient) on the situation that it’s for use by the recipient for data functions solely (and never for the analysis of any funding, acquisition, disposal or every other transaction). Any failure to adjust to these restrictions could represent a violation of relevant securities legal guidelines. The corporations in which Takeda instantly and not directly owns investments are separate entities. In this press launch, “Takeda” is typically used for comfort the place references are made to Takeda and its subsidiaries in normal. Likewise, the phrases “we,” “us” and “our” are additionally used to seek advice from subsidiaries in normal or to those that work for them. These expressions are additionally used the place no helpful goal is served by figuring out the actual firm or corporations.

Forward-Looking Statements

This press launch and any supplies distributed in reference to this press launch could comprise forward-looking statements, beliefs or opinions concerning Takeda’s future business, future place and outcomes of operations, together with estimates, forecasts, targets and plans for Takeda. Without limitation, forward-looking statements usually embody phrases akin to “targets,” “plans,” “believes,” “hopes,” “continues,” “expects,” “aims,” “intends,” “ensures,” “will,” “may,” “should,” “would,” “could” “anticipates,” “estimates,” “projects” or related expressions or the destructive thereof. These forward-looking statements are based mostly on assumptions about many vital components, together with the next, which might trigger precise outcomes to vary materially from these expressed or implied by the forward-looking statements: the financial circumstances surrounding Takeda’s world business, together with normal financial circumstances in Japan and the United States; aggressive pressures and developments; adjustments to relevant legal guidelines and rules, together with world well being care reforms; challenges inherent in new product improvement, together with uncertainty of scientific success and selections of regulatory authorities and the timing thereof; uncertainty of industrial success for new and current merchandise; manufacturing difficulties or delays; fluctuations in curiosity and forex trade charges; claims or considerations concerning the protection or efficacy of marketed merchandise or product candidates; the influence of well being crises, just like the novel coronavirus pandemic, on Takeda and its prospects and suppliers, together with international governments in nations in which Takeda operates, or on different aspects of its business; the timing and influence of post-merger integration efforts with acquired corporations; the flexibility to divest belongings that aren’t core to Takeda’s operations and the timing of any such divestment(s); and different components recognized in Takeda’s most up-to-date Annual Report on Form 20-F and Takeda’s different reviews filed with the U.S. Securities and Exchange Commission, out there on Takeda’s web site at: https://www.takeda.com/investors/sec-filings/ or at www.sec.gov. Takeda doesn’t undertake to replace any of the forward-looking statements contained in this press launch or every other forward-looking statements it could make, besides as required by regulation or inventory trade rule. Past efficiency just isn’t an indicator of future outcomes and the outcomes or statements of Takeda in this press launch will not be indicative of, and aren’t an estimate, forecast, assure or projection of Takeda’s future outcomes.

Medical data

This press launch comprises details about merchandise that will not be out there in all nations, or could also be out there beneath totally different logos, for totally different indications, in totally different dosages, or in totally different strengths. Nothing contained herein must be thought of a solicitation, promotion or commercial for any pharmaceuticals together with those beneath improvement.

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¹ Takeda. QDENGA Summary of Product Characteristics. Retrieved August 2022.

² World Health Organization. Fact Sheet. Dengue and Severe Dengue. January 2022. Retrieved August 2022.

³ Shepard DS, Undurraga EA, Halasa YA. Economic and illness burden of dengue in Southeast Asia. PLoS Negl Trop Dis. 2013;7(2). doi:10.1371/journal.pntd.0002055

⁴ Sasmono, R.T., et al. Distinct Dengue Disease Epidemiology, Clinical, and Diagnosis Features in Western, Central, and Eastern Regions of Indonesia, 2017 – 2019. Front Med. 2020;7:582235.

⁵ Received from Ministry of Health Republic Indonesia. Data Penambahan Kasus DBD Tahun 2022. Received July 20, 2022.

⁶ Tricou, V. Efficacy and Safety of Takeda’s Tetravalent Dengue Vaccine Candidate (TAK-003) After 4.5 Years of Follow-Up. Presented on the eighth Northern European Conference of Travel Medicine; June 2022.

⁷ Huang CY-H, et al. Genetic and phenotypic characterization of manufacturing seeds for tetravalent dengue vaccine (DENVax). PLoS Negl Trop Dis. 2013;7:e2243.

⁸ Biswal S, et al. Efficacy of a tetravalent dengue vaccine in wholesome kids and adolescents. N Engl J Med. 2019;2019;381:2009-2019.

⁹ Biswal S, et al. Efficacy of a tetravalent dengue vaccine in wholesome kids aged 4-16 years: a randomized, placebo managed, part 3 trial. Lancet. 2020. 2020;395:1423-1433.

¹⁰ The European Medicines Agency. Medicines for use outdoors the EU — EU-M4all. July 2020. Retrieved August 2022.

¹¹ Gov. Efficacy, Safety and Immunogenicity of Takeda’s Tetravalent Dengue Vaccine (TDV) in Healthy Children (TIDES). Retrieved August 2022.

¹² World Health Organization. Ten threats to world well being in 2019. 2019. Retrieved August 2022.

¹³ Guzman MG, et al. Dengue: a unbroken world risk. Nature Reviews Microbiology. 2010;8:S7-S16.

¹⁴ Knowlton Ok, et al. Mosquito-Borne Dengue Fever Threat Spreading in the Americas. The Natural Resources Defense Council (NRDC). 2009. Retrieved August 2022.

¹⁵ Chan E, et al. Using internet search question information to observe dengue epidemics: a brand new mannequin for uncared for tropical illness surveillance. PLoS Negl Trop Dis. 2011;5:e1206.

¹⁶ Centers for Disease Control and Prevention. About Dengue: What You Need to Know. May 2019. Retrieved August 2022.

¹⁷ World Health Organization. Vaccines and immunization. 2022. Retrieved August 2022.

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