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.
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With Qdenga’s US approval process moving ahead with the granting of a Priority Review and the dengue vaccine's first market launch, in Indonesia, expected early next year, Takeda has recently referred to plans to expand the product into other countries as well. But precise timings as yet remain unclear.
Takeda could soon learn whether the European Medicines Agency will recommend in favor of approving its dengue vaccine, which was reviewed under a new evaluation route that simultaneously targets EU and non-EU countries.
Takeda’s dengue vaccine Qdenga has received its global first approval in Indonesia, as Qdenga, also marking the first time for the firm to market a vaccine outside Japan and potentially paving the way to wider global use of vaccines for the mosquito-borne disease following setbacks for earlier contenders.