Gilead: EMA validates marketing application for filgotinib

(CercleFinance.com) - Gilead and Galapagos say that the European Medicines Agency (EMA) has validated the application for Marketing Authorisation (MA) for filgotinib, a candidate drug for the treatment of adults with rheumatoid arthritis.


The file will now be reviewed by the EMA under a centralised licensing procedure for all 28 EU Member States, as well as Norway, Iceland and Lichtenstein. A similar dossier will be filed in the US by the end of the year.

For the record, both laboratories signed a 10-year R&D collaboration agreement last month, giving Gilead access to an innovative Galapagos portfolio and marketing rights outside Europe.


Copyright (c) 2019 CercleFinance.com. All rights reserved.