CHMP Gives Positive Opinion on Takeda’s Qdenga
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has given its approval to Takeda GmbH’s Qdenga, a live, attenuated dengue tetravalent vaccine (TAK-003). It is the first time the CHMP has reviewed a medicinal product for the EU market in a centralized procedure at the same time as a medicinal product for non-EU countries under the ‘Eu-Medicines for all’ program (EU-M4all). The EMA’s approval is expected within a few months.
Dengue fever, a mosquito-borne tropical disease, is prevalent in over 100 countries, including Europe (only nine countries had experienced severe ...