EU regulator approves Dexilant for GERD-Takeda

The European decentralised procedure was positively concluded for Dexilant (dexlansoprazole), from Takeda. The drug is a proton pump inhibitor (PPI) with a new dual-delayed release technology for the treatment of GERD. The regulatory process has now entered into the national phase in which the involved member states can adopt a national decision and grant national marketing authorization.

Sweden was the first country to approve dexlansoprazole in the EU, followed by Lithuania, Belgium, Germany and Ireland. Takeda anticipates further national approvals and market launches from Q4 FY13. The application for marketing authorization in 16 countries through the DCP was submitted in March 2012 with Portugal serving as its Reference Member State.