Takeda Receives Positive CHMP Opinion Recommending Approval of Dengue Vaccine Candidate in EU and Dengue-Endemic Countries

• TAK-003 Recommended for the Prevention of Dengue Disease Caused by Any Dengue Virus Serotype in Individuals Four Years of Age and Older in the EU and in Dengue-Endemic Countries Participating in the EU-M4all Procedure
• Positive Opinion for TAK-003 Based on 4.5 Years of Safety and Efficacy Data from Pivotal Phase 3 Trial of Over 20,000 Children and Adolescents Across Eight Dengue-Endemic Countries
• Marketing Authorization Expected in Coming Months in Europe Followed by Regulatory Decisions in Latin America and Asia

Takeda (TSE:4502/NYSE:TAK) right now introduced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) really helpful the approval of Takeda’s dengue vaccine candidate, TAK-003, for the prevention of dengue illness attributable to any serotype in people 4 years of age and older in Europe and in dengue-endemic international locations taking part in the parallel EU-M4all process. The closing step in the trail to approval in Europe is Marketing Authorization from the EMA, which is predicted in the approaching months. Regulatory evaluations may also progress in dengue-endemic international locations in Latin America and Asia.

“We are one step closer towards the approval of a dengue vaccine that could benefit many of the millions of individuals around the world exposed to dengue. This is a major moment for the global health community, European countries and the dengue-endemic countries that participated in the EU-M4all procedure,” stated Gary Dubin, M.D., president of the Global Vaccine Business Unit at Takeda. “We have been working for many years to help improve the way dengue can be prevented. Our efforts to provide a new option for dengue prevention support Takeda’s overall goal to provide long-term societal value to the people we serve.”

The incidence of dengue has grown dramatically all over the world in latest many years, inflicting an estimated 390 million infections and 500,000 hospitalizations yearly.^1,2 The rise in instances might be attributed to elements equivalent to urbanization, globalization and local weather change.¹ Severe dengue accounts for about 5% of dengue instances and is a number one trigger of critical sickness and loss of life amongst youngsters and adults in Latin America and Asia.^3,4 Dengue is the second most identified trigger of fever in vacationers returning to Europe from endemic international locations.⁵ Its presence is far-reaching in endemic international locations throughout the Americas, South-East Asia and Western Pacific areas and is rising in non-endemic areas in continental Europe, together with France, Italy, Germany, Spain and the United States.⁶

“The global health community has been eager for a dengue vaccine that is accessible without the barrier of pre-vaccination testing,” stated Dr. Ooi Eng Eong, Professor of Emerging Infectious Diseases at Duke-NUS Medical School in Singapore. “The robust clinical data provided by Takeda shows that its dengue vaccine has the potential to help prevent dengue cases and hospitalizations. Today, we are closer to helping improve dengue prevention and reducing the burden of disease on countries, communities and health systems.”

The Committee’s optimistic opinion was supported by outcomes throughout 5 Phase 1, 2 and 3 trials with greater than 28,000 youngsters and adults. This consists of 4 and a half years of follow-up information from the worldwide, pivotal Phase 3 Tetravalent Immunization towards Dengue Efficacy Study (TIDES) trial, according to the World Health Organization’s (WHO) advice to acquire three to 5 years of follow-up information after the completion of a main dengue vaccination in order to most precisely assess security and efficacy.⁷ TIDES exploratory analyses confirmed that all through the 4 and a half years of examine follow-up, TAK-003 prevented 84% of hospitalized dengue instances and 61% of symptomatic dengue instances in the general inhabitants, together with each seropositive and seronegative people. TAK-003 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, up to now.

In August 2022, Takeda’s dengue vaccine, generally known as QDENGA^® ▼ (Dengue Tetravalent Vaccine [Live, Attenuated]) (TAK-003), was accredited by the Indonesia National Agency for Drug and Food Control, BADAN POM, for the prevention of dengue illness by any serotype in people six years to 45 years of age. TAK-003 has not but been accredited anyplace else in the world and Takeda will proceed to provoke and progress regulatory filings in different dengue-endemic and non-endemic international locations. Regulatory approval and use of the vaccine depends on analysis by related native authorities and for the indication they deem acceptable.

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

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

The CHMP’s optimistic advice has no influence on the total yr consolidated reported forecast for the fiscal yr ending March 31, 2023 (Fiscal Year 2022).

Takeda will maintain a TAK-003 Investor Event in December 2022 to supply extra element on business planning and updates on regulatory progress.

About Dengue

Dengue is a mosquito-borne viral illness that spreads quickly all over the world and was one of the WHO’s high 10 threats to international well being in 2019.⁸ Dengue is especially unfold by Aedes aegypti mosquitoes and, to a lesser extent, Aedes albopictus mosquitoes.¹ It is attributable to any of 4 dengue virus serotypes, every of which might trigger dengue fever or extreme dengue. The prevalence of particular person serotypes varies throughout completely different geographies, international locations, areas, seasons and over time.² Recovery from an infection by one serotype supplies lifelong immunity towards solely that serotype, and later publicity to any of the remaining serotypes is related to an elevated threat of extreme illness.¹

About TAK-003

Takeda’s tetravalent dengue vaccine candidate (TAK-003) relies on a live-attenuated dengue serotype 2 virus, which supplies the genetic “backbone” for all 4 vaccine viruses.⁹ Clinical Phase 2 information in youngsters and adolescents confirmed that TAK-003 induced immune responses towards all 4 dengue serotypes, in each seropositive and seronegative members, which endured by means of 48 months after vaccination, and the vaccine was discovered to be usually protected and effectively tolerated.¹⁰ The pivotal Phase 3 Tetravalent Immunization towards Dengue Efficacy Study (TIDES) trial met its main endpoint of total vaccine efficacy (VE) towards virologically-confirmed dengue (VCD) at 12-months follow-up and all secondary endpoints at 18-months follow-up for which there have been a ample quantity of dengue instances, together with VE towards hospitalized dengue and VE in baseline seropositive and baseline seronegative people.^11,12 Efficacy diversified by serotype. The outcomes demonstrated TAK-003 was usually effectively tolerated, and there have been no vital security dangers noticed up to now.

About EU-M4all¹³

EU-M4all (or EU-Medicines for all) is a process designed to facilitate affected person entry to important medicines or vaccines meant to assist stop or deal with illnesses of main public well being curiosity. Through the EU-M4all process (beforehand generally known as 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 illnesses which can be meant for markets outdoors of the EU which have registered in the process.

About the Phase 3 TIDES (DEN-301) Trial

The double-blind, randomized, placebo-controlled Phase 3 Tetravalent Immunization towards 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 resulting from any of the 4 dengue virus serotypes in youngsters and adolescents. The TIDES trial is Takeda’s largest interventional medical trial up to now and enrolled over 20,000 wholesome youngsters and adolescents ages 4 to 16 years residing in dengue-endemic areas.¹¹ Study members have been randomized 2:1 to obtain two doses of TAK-003 0.5 mL or placebo on Months 0 and 3, administered subcutaneously.¹¹ The examine is comprised of 5 elements. Part 1 and the first endpoint evaluation evaluated vaccine efficacy (VE) and security by means of 12 months after the second dose.¹¹ 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 towards hospitalized dengue.¹¹ Part 3 evaluated VE and long-term security by following members for a further two and a half to a few years, as per WHO suggestions.¹⁴ 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 yr after completion of Part 4.¹⁴

The trial is going down 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 youngsters.¹⁴ Baseline blood samples have been collected from all people taking part in the trial to permit for analysis of security and efficacy primarily based on serostatus. Takeda and an impartial Data Monitoring Committee of specialists are actively monitoring security on an ongoing foundation.

Takeda’s Commitment to Vaccines

Vaccines stop 3.5 to five million deaths annually and have reworked international public well being.¹⁵ For greater than 70 years, Takeda has provided vaccines to guard the well being of folks in Japan. Today, Takeda’s international vaccine business is making use of innovation to sort out some of the world’s most difficult infectious illnesses, equivalent to dengue, COVID-19, pandemic flu and Zika. Takeda’s group brings an excellent observe report 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 folks 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 growing extremely revolutionary medicines that contribute to creating a distinction in folks’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 staff are dedicated to enhancing high quality of life for sufferers and to working with our companions in well being care in roughly 80 international locations 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) will not be meant to, and doesn’t represent, signify or type half of any provide, invitation or solicitation of any provide to buy, in any other case purchase, subscribe for, alternate, 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 below 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 supplied to the recipient) on the situation that it’s to be used by the recipient for data functions solely (and not for the analysis of any funding, acquisition, disposal or another transaction). Any failure to adjust to these restrictions could represent a violation of relevant securities legal guidelines.

The corporations in which Takeda immediately 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 common. Likewise, the phrases “we”, “us” and “our” are additionally used to consult with subsidiaries in common or to those that work for them. These expressions are additionally used the place no helpful function 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 typically embody phrases equivalent to “targets”, “plans”, “believes”, “hopes”, “continues”, “expects”, “aims”, “intends”, “ensures”, “will”, “may”, “should”, “would”, “could” “anticipates”, “estimates”, “projects” or comparable expressions or the adverse thereof. These forward-looking statements are primarily based on assumptions about many vital elements, together with the next, which may trigger precise outcomes to vary materially from these expressed or implied by the forward-looking statements: the financial circumstances surrounding Takeda’s international business, together with common financial circumstances in Japan and the United States; aggressive pressures and developments; adjustments to relevant legal guidelines and rules, together with international well being care reforms; challenges inherent in new product improvement, together with uncertainty of medical success and selections of regulatory authorities and the timing thereof; uncertainty of business success for brand spanking new and present merchandise; manufacturing difficulties or delays; fluctuations in curiosity and foreign money alternate charges; claims or issues 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 clients and suppliers, together with overseas governments in international locations in which Takeda operates, or on different sides of its business; the timing and influence of post-merger integration efforts with acquired corporations; the power to divest property that aren’t core to Takeda’s operations and the timing of any such divestment(s); and different elements 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, obtainable 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 another forward-looking statements it could make, besides as required by regulation or inventory alternate rule. Past efficiency will not be an indicator of future outcomes and the outcomes or statements of Takeda in this press launch will not be indicative of, and will not be an estimate, forecast, assure or projection of Takeda’s future outcomes.

Medical data

This press launch comprises details about merchandise that will not be obtainable in all international locations, or could also be obtainable below completely different logos, for various indications, in completely different dosages, or in completely different strengths. Nothing contained herein needs to be thought of a solicitation, promotion or commercial for any pharmaceuticals together with those below improvement.

1. World Health Organization. Fact Sheet. Dengue and Severe Dengue. January 2022. Retrieved August 2022.
2. Guzman MG, Halstead SB, Artsob H, et al. Dengue: a unbroken international risk. Nat Rev Microbiol. 2010;8(12 Suppl):S7-S16. doi:10.1038/nrmicro2460.
3. Knowlton Ok, et al. Mosquito-Borne Dengue Fever Threat Spreading in the Americas. The Natural Resources Defense Council (NRDC). 2009. Retrieved April 2022.
4. Centers for Disease Control and Prevention. Dengue For Healthcare Providers Clinical Presentation. September 2021. Retrieved October 2022.
5. Bulugahapitiya, U., Siyambalapitiya, S., Seneviratne, S. L., & Fernando, D. J. (2007). Dengue fever in travellers: A problem for European physicians. European journal of inside medication, 18(3), 185–192. https://doi.org/10.1016/j.ejim.2006.12.002
6. European Centre for Disease Prevention and Control (ECDC). Autochthonous transmission of dengue virus in EU/EEA, 2010-present. https://www.ecdc.europa.eu/en/all-topics-z/dengue/surveillance-and-disease-data/autochthonoustransmission-dengue-virus-eueea.
7. WHO Technical Report Series No. 979, 2013 Annex 2. Guidelines on the standard, security and efficacy of dengue tetravalent vaccines (reside, attenuated). https://cdn.who.int/media/docs/default-source/biologicals/vaccine-standardization/dengue/trs-979-annex-2-dengue.pdf?sfvrsn=bd659777_2&download=true.
8. World Health Organization. Ten threats to international well being in 2019. 2019. Retrieved October 2022.
9. Huang CY-H, et al. Genetic and phenotypic characterization of manufacturing seeds for tetravalent dengue vaccine (DENVax). PLoS Negl Trop Dis. 2013;7:e2243.
10. Tricou, V, Sáez-Llorens X, et al. Safety and immunogenicity of a tetravalent dengue vaccine in youngsters aged 2-17 years: a randomised, placebo-controlled, section 2 trial. 2020. doi:10.1016/S0140-6736(20)30556-0.
11. Biswal S, et al. Efficacy of a tetravalent dengue vaccine in wholesome youngsters and adolescents. N Engl J Med. 2019; 2019;381:2009-2019.
12. Biswal S, et al. Efficacy of a tetravalent dengue vaccine in wholesome youngsters aged 4-16 years: a randomized, placebo managed, section 3 trial. Lancet. 2020. 2020;395:1423-1433.
13. The European Medicines Agency. Medicines to be used outdoors the EU — EU-M4all. July 2020. Retrieved October 2022.
14. Gov. Efficacy, Safety and Immunogenicity of Takeda’s Tetravalent Dengue Vaccine (TDV) in Healthy Children (TIDES). Retrieved August 2022.
15. World Health Organization. Vaccines and immunization. 2022. Retrieved August 2022.

View supply model on businesswire.com: https://www.businesswire.com/news/home/20221013006022/en/