Galapagos: EMA validates marketing application for Filgotini
(CercleFinance.com) - The Belgo-Dutch pharmaceutical research company Galapagos and Gilead 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.
The application is supported by 24-week data from the Phase 3 FINCH clinical trials, in which once-daily treatment with filgotinib achieved improvements in clinical signs and symptoms.
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