Galapagos NV announced that 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) for Great Britain. The MHRA has licensed an additional indication for Jyseleca, an oral once-daily, JAK1 preferential inhibitor, for use in adult patients 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. The submission was supported by data from the Phase 2b/3 SELECTION program, published in the Lancet.

The decision from the MHRA follows authorisation from the European Commission (EC) for use in the same patient population.