1. Pink Sheet
  2. >>Pathways & Standards
  3. >>Review Pathways

Takeda Test Drives EMA’s Parallel Review Route For EU And Non-EU Markets

Company Submits Two Sets Of Applications For Evaluation Of Its Dengue Vaccine To CHMP

 
• By Vibha Sharma

A new evaluation route that the European Medicines Agency launched last year came at the right time for Takeda’s dengue vaccine candidate. 

Dengue - Phrase in History of the Present Illness
Dengue is the most rapidly spreading mosquito-borne disease • Source: Alamy

A dengue vaccine that has been in the making for 15 years will become the first ever product to undergo the European Medicines Agency’s new mechanism that allows for the parallel review of products for use in the EU and non-EU markets.

The product is TAK-003, Takeda’s tetravalent dengue vaccine candidate for the prevention of the mosquito-borne disease in individuals aged 4-60 years

Dramatic Rise Of Dengue

Dengue is the most rapidly spreading mosquito-borne disease globally, with over 50 million cases occurring every year. Before 1970, only nine countries had experienced severe dengue epidemics, but the disease is now endemic in more than 100 countries, according to the World Health Organization.

The dengue-causing virus DENV has four serotypes, which means its possible to get infected four times

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Review Pathways

More from Pathways & Standards

US FDA Adcomm To Consider If Genentech’s Columvi Study Generalizable To US

 
• By Sue Sutter

Patients from Asia saw a differential treatment effect versus non-Asian regions in the Phase III multiregional study, with an adverse survival trend seen in the latter group, the FDA said about the lymphoma drug.

Califf In Conversation: ‘Decimated’ US FDA Teams Endanger Innovation

 
• By Barnaby Pickering

Pink Sheet sister publication In Vivo spoke to the former FDA commissioner about the recent layoffs and their impact on vaccine and other product development.

New EU Filings

 
• By Neena Brizmohun

Brensocatib, Insmed's investigational treatment for non-cystic fibrosis bronchiectasis, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.