OSAKA: Japan-headquartered Takeda Pharmaceutical Company Ltd., a global R&D driven biopharmaceutical leader, recently announced that the European Medicines Agency (EMA) has accepted the company's filing packages for its tetravalent dengue vaccine candidate (TAK-003) which is being investigated for the prevention of dengue due to any dengue virus serotype in individuals aged four to 60. Takeda intends to submit regulatory filings in Argentina, Brazil, Colombia, Indonesia, Malaysia, Mexico, Singapore, Sri Lanka, and Thailand by this year. TAK-003 is based on a live attenuated dengue serotype 2 virus, which provides the genetic "backbone" for all four vaccine viruses. Approximately half of the world now lives under the threat of dengue, which is estimated to cause 390 million infections and around 20,000 deaths globally each year. The dengue virus can infect people of all ages and is a leading cause of serious illness among children in some countries in Latin America & Asia.
Commenting on the development, Derek Wallace, Vice-President, Dengue Global Program Leader at Takeda said, "Submission of regulatory filings for TAK-003 marks an important development for people who are living in or traveling to communities burdened by the threat of dengue." He further added, "Dengue outbreaks, which result in half a million hospitalizations globally each year, can overwhelm communities and governments because of the broad impact on the healthcare system. With limited options to prevent the disease, there is a pressing need for widely available dengue vaccines. Takeda is committed to working with regulatory authorities and recommending bodies to support the evaluation of our submissions and achieve access for TAK-003."
Takeda is participating in the EMA's first-ever parallel assessment of a medicinal product for use in the European Union (EU), and through the EU-M4all procedure (or EU-Medicines for all and previously known as Article 58 procedure, which is designed to facilitate patient access to essential medicines or vaccines intended to prevent or treat diseases of major public health interest) for countries outside of the EU. Along with the scientific opinion issued by the Committee for Medicinal Products for Human use (CHMP), national regulators in countries participating in the EU-M4all procedure will conduct their own assessments to determine if national marketing authorizations for TAK-003 are granted. Takeda is also seeking approval of TAK-003 in dengue-endemic countries that are not participating in the EU-M4all procedure.
The regulatory submissions for TAK-003 include long-term safety and efficacy data through 36 months from the ongoing pivotal Phase-3 Tetravalent Immunization against Dengue Efficacy Study (TIDES) trial. Takeda intends to present and publish details of the 36-month data at a scientific meeting and in a peer-reviewed journal this year.
Meanwhile, Takeda is soon expected to submit regulatory filings in the US, followed by additional countries in Asia and Latin America.
