Takeda (TAK) Begins Regulatory Submissions for Dengue Vaccine Candidate in EU and Dengue-Endemic Countries
- Stocks off record highs ahead of earnings, U.S. data
- Microsoft (MSFT) Near Deal to Acquire Nuance (NUAN) - Report
- Alibaba (BABA) Gets a Record $2.8 Billion Anti-Monopoly Fine, Shares Soar as a 'Major Overhang' is Lifted
- Tesla (TSLA) Upgraded to 'Buy' at Canaccord Genuity and PT Raised by 155%, as it 'Holds a Several-Year Lead' in EV While Storage Business Accelerates
- Dollar bounces higher as traders brace for inflation data
News and research before you hear about it on CNBC and others. Claim your 1-week free trial to StreetInsider Premium here.
Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) (“Takeda”) today announced that the European Medicines Agency (EMA) has accepted the Company’s filing packages for its dengue vaccine candidate (TAK-003) which is being investigated for the prevention of dengue due to any dengue virus serotype in individuals ages four to 60. Takeda intends to submit regulatory filings in Argentina, Brazil, Colombia, Indonesia, Malaysia, Mexico, Singapore, Sri Lanka and Thailand during 2021.
“Submission of regulatory filings for our dengue vaccine candidate, TAK-003, marks an important development for people who are living in or traveling to communities burdened by the threat of dengue,” said Derek Wallace, VP, Dengue Global Program Leader at Takeda. “Dengue outbreaks, which result in half a million hospitalizations globally each year, can overwhelm communities and governments because of the broad impact on the health care 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 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 (previously Article 58) procedure 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.
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.
Takeda also intends to submit regulatory filings in the United States, followed by additional countries in Asia and Latin America.
EU-M4all (or EU-Medicines for all) is a procedure designed to facilitate patient access to essential medicines or vaccines intended to prevent or treat diseases of major public health interest. Through the EU-M4all procedure (previously known as the Article 58 procedure), the EMA, in cooperation with the World Health Organization (WHO), can provide scientific opinion on medicines and vaccines for public health priority diseases that are intended for markets outside of the EU.
Serious News for Serious Traders! Try StreetInsider.com Premium Free!
You May Also Be Interested In
- 9 Meters Biopharma (NMTR) and Celiac Disease Foundation Report Collaboration to Support Clinical Trial Enrollment in 9 Meters' Phase 3 CeDLara Study
- Taysha Gene Therapies (TSHA) Acquires Exclusive Worldwide Rights to Clinical-Stage AAV9 Gene Therapy Program
- Medicenna (MDNA) Presents Preclinical Data Demonstrating Potent Immune Modulating Effects of an IL-2/IL-13 Dual Specific Cytokine at the 2021 AACR
Create E-mail Alert Related CategoriesCorporate News, FDA
Related EntitiesDefinitive Agreement
Sign up for StreetInsider Free!
Receive full access to all new and archived articles, unlimited portfolio tracking, e-mail alerts, custom newswires and RSS feeds - and more!