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

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

More from Review Pathways

More from Pathways & Standards

US FDA Vaccine Framework Coming In Weeks, But Details Vague

 

New CBER Director Prasad will "unleash a massive" framework on vaccines, FDA Commissioner Marty Makary said 15 May, raising questions about the impact on products nearing approval.

UK’s International Recognition Procedure: EU Dossier Faster Than US Or Canada

 

Companies that use the European Medicines Agency as a reference regulator for the UK’s International Recognition Procedure can expect a faster approval than those that use other national regulators, such as those in the US and Canada, an MHRA spokesperson has said.

HHS Secretary Kennedy Says Trump Will Make Final Decision On Mifepristone Policy

 

With an FDA review ongoing, Kennedy’s admission, made during a Senate hearing on the Health and Human Services Department’s budget request, suggests political officials could supersede scientific decisions.