Posted by Michael Wonder on 27 Jul 2020
Gilead and Galapagos announce positive European CHMP opinion for Jyseleca (filgotinib) for the treatment of adults with moderate to severe rheumatoid arthritis
24 June 2020 - Clinical development program of filgotinib demonstrated durable efficacy balanced with a consistent safety profile in rheumatoid arthritis through 52 weeks.
Gilead Sciences and Galapagos announced today the EMA's CHMP has adopted a positive opinion for Jyseleca (filgotinib 200 mg and 100 mg tablets), an investigational, once-daily, oral, selective JAK1 inhibitor for the treatment of adults with moderate to severe rheumatoid arthritis who have responded inadequately or are intolerant to one or more disease modifying anti-rheumatic drugs.
The CHMP positive opinion is a scientific recommendation to the European Commission to grant marketing authorisation in Europe.
