Takeda's Tetravalent Dengue Vaccine TAK-003 Enters EMA Review: Global Regulatory Submissions Planned for 2021

March 27, 2021/BioValleyBIOON/--Takeda Pharmaceutical Company Limited (Takeda) recently announced that the European Medicines Agency (EMA) has accepted its application for the dengue vaccine TAK-003, which is being developed for individuals aged 4 to 60 years to prevent dengue fever caused by any dengue virus serotype. The company plans to submit regulatory filings in Argentina, Brazil, Colombia, Indonesia, Malaysia, Mexico, Singapore, Sri Lanka, and Thailand during 2021. Takeda also intends to submit regulatory filings in the United States, followed by submissions in other countries across Asia and Latin America.

Takeda will participate in the first-ever parallel assessment of a medicinal product conducted by the European Medicines Agency (EMA), under which countries outside the European Union will conduct their evaluations through the EU-M4all (formerly Article 58) procedure. In addition to the scientific opinion issued by the EMA’s Committee for Medicinal Products for Human Use (CHMP), regulatory authorities in countries participating in the EU-M4all procedure will carry out their own assessments to determine whether to grant national marketing authorization for TAK-003. Takeda is also seeking approval for TAK-003 in dengue-endemic countries that are not participating in the EU-M4all procedure.

TAK-003 is a live attenuated tetravalent dengue vaccine developed based on the attenuated dengue virus serotype 2 (DENV-2), which provides protection against all four vaccine virusesGeneticsLearn the framework. Data from Phase II clinical studies in children and adolescents demonstrated that TAK-003 induced neutralizing antibodies against all four dengue virus serotypes across age groups and in both seropositive and seronegative individuals, with a favorable safety and tolerability profile. The pivotal Phase III TIDES trial met its primary endpoint of overall vaccine efficacy (VE) against virologically confirmed dengue (VCD) at 12 months of follow-up, and achieved all secondary endpoints at 18 months of follow-up, including VE against hospitalized dengue and VE in baseline seropositive and baseline seronegative individuals. The VE of TAK-003 varied by serotype. Study results indicated that TAK-003 was well tolerated, with no significant safety risks observed to date.

Derek Wallace, Vice President and Global Program Lead for Dengue at Takeda, stated: “The submission of regulatory filings for our dengue vaccine, TAK-003, marks a significant milestone for individuals living in or traveling to communities affected by dengue. Dengue epidemics result in 500,000 hospitalizations annually worldwide, placing a substantial burden on healthcare systems. Given the limited options for dengue prevention, there is an urgent need for the widespread use of dengue vaccines. Takeda is committed to collaborating with regulatory authorities and advocacy organizations to support the review of our submission and facilitate access to TAK-003.”

The regulatory dossier for TAK-003 includes 36-month long-term safety and efficacy data from the ongoing pivotal Phase 3 tetravalent dengue immunogenicity and efficacy study (TIDES). Takeda intends to present these findings at a scientific conference later this year.Meetingand details of the 36-month data were published in a peer-reviewed journal.

Currently, there is only one dengue vaccine product available on the global market: Dengvaxia, developed over a period of 20 years by the French pharmaceutical giant Sanofi. This vaccine was approved in Mexico in December 2015, becoming the first dengue vaccine to receive regulatory approval worldwide. Subsequently, it gained approval in multiple dengue-endemic countries across Latin America and Asia, and was approved by the European Union in December 2018. In the United States, Dengvaxia received approval in May 2019FDAApproved as the first medical preventive tool for dengue fever in the U.S. market.

Dengue fever (Dengue) is an acute arboviral infectious disease caused by the dengue virus and transmitted via mosquito vectors. Clinical manifestations include high fever, headache, severe myalgia and arthralgia, rash, hemorrhagic tendency, lymphadenopathy, leukopenia, and thrombocytopenia. Dengue fever is one of the leading causes of death among children in Southeast Asia.

Dengue fever, commonly known as "breakbone fever," is the fastest-spreading mosquito-borne viral disease and was listed by the World Health Organization (WHO) as one of the top ten global health threats in 2019. Dengue fever is primarily transmitted by Aedes aegypti mosquitoes, followed by Aedes albopictus. It is caused by any one of the four dengue virus serotypes, each of which can cause either dengue fever or severe dengue. The prevalence of individual serotypes varies across different geographies, countries, regions, and seasons, as well as over time. Recovery from infection with one serotype provides lifelong immunity only against that specific serotype; subsequent exposure to any other serotype increases the risk of developing severe disease.

Dengue fever is prone to epidemics, with outbreaks occurring in tropical and subtropical regions; recently, outbreaks have also been reported in parts of the continental United States and Europe. Approximately half of the world’s population now lives under the threat of dengue. Globally, it is estimated that dengue causes 390 million infections and approximately 20,000 deaths annually. The dengue virus can infect individuals of all ages and is a leading cause of severe illness among children in some countries in Latin America and Asia.。

Currently, there are no specific therapeutic agents available for dengue hemorrhagic fever. Dengue fever is caused by four distinct serotypes of the dengue virus; since immunity to one serotype does not confer cross-protection against the others, individuals can be repeatedly infected by different dengue virus serotypes. (Bioon.com)

Original Source: Takeda Begins Regulatory Submissions for Dengue Vaccine Candidate in EU and Dengue-Endemic Countries