MHRA approval for Galapagos' Jyseleca in UC

19 January 2022

UK regulator the Medicines and Healthcare products Regulatory Agency (MHRA) has granted a marketing authorization for Jyseleca (filgotinib 200mg tablets), as a new treatment for ulcerative colitis (UC) in Great Britain.

The JAK1 preferential inhibitor, which is being jointly developed and commercialized by Gilead Sciences (Nasdaq: GILD) and Galapagos (AMS: GLPG), is already approved in Great Britain, the European Union and Japan for the treatment of adults with moderate to severe active rheumatoid arthritis who have responded inadequately or are intolerant to one or more disease modifying anti-rheumatic drugs.

Now the MHRA has licensed an additional indication for Jyseleca for use in adults with moderately to severely active UC who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic agent.

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