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Shaking Off US Rebuff, Gilead And Galapagos Get Filgotinib Green Lights In EU And Japan

First Ever Approvals For Belgian Biotech

 
• By Kevin Grogan

Galapagos and Gilead's JAK inhibitor has been approved for rheumatoid arthritis in the second and third biggest pharma markets, softening the blow somewhat of rejection from the US FDA in the biggest market last month.  

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Filgotinib hits regulatory bullseye in EU and Japan • Source: Shutterstock

Filgotinib may have been surprisingly rejected by US regulators last month, but their counterparts in Europe and Japan had no surprises for Galapagos NV and Gilead Sciences, Inc. and have approved the potential rheumatoid arthritis (RA) blockbuster, to be marketed as Jyseleca.

The European Commission and the Japanese Ministry of Health, Labour and Welfare have approved both 200mg and 100mg tablets of Jyseleca, a once-daily oral JAK1 inhibitor for the treatment of RA in patients who have not responded to one or more disease modifying anti-rheumatic drugs (DMARDs)

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