Posted by Michael Wonder on 07 Feb 2017
Ariad announces submission of marketing authorisation application for brigatinib to the European Medicines Agency
6 February 2017 - Ariad Pharmaceuticals today announced the submission of a marketing authorisation application for its investigational oral anaplastic lymphoma kinase inhibitor, brigatinib, to the EMA.
ARIAD is seeking marketing approval in the European Union of brigatinib in adult patients with anaplastic lymphoma kinase non-small cell lung cancer who have been previously treated with crizotinib.
The U.S. FDA is currently reviewing a new drug application for brigatinib filed by ARIAD and has set an action date of 29 April 2017 under the Prescription Drug User Fee Act.
