Jyseleca (filgotinib) is a once-daily (QD), oral selective Janus kinase (JAK)-1 inhibitor developed through a partnership by Galapagos and Gilead, that received approval for the treatment of moderate-to-severe ulcerative colitis (UC) in Europe in November 2021, as the second JAK inhibitor approved in the EU behind Pfizer’s Xeljanz (tofacitinib).
At the European Crohn’s and Colitis Organisation (ECCO) 2023 Congress, Galapagos presented new efficacy and safety data of continued filgotinib 200mg (FIL200) therapy for the treatment of patients with UC in the continuing SELECTION long-term extension (LTE) (NCT02914535) study, reporting data from LTE Week 144 in completers and LTE Week 192 in non-responders, respectively, representing a total of 3.9 years of treatment each. In SELECTION, adults with moderately-to-severely active UC received induction (IND) FIL200, filgotinib 100mg (FIL100), or placebo four times a day for 11 weeks. Patients in clinical remission or with a Mayo Clinic Score (MCS) response at week ten (responders) could enter the 47-week maintenance study.
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The results indicated that FIL200 was effective in maintaining symptomatic remission and health-related quality of life for up to four years. This analysis included 148 completers and 372 non-responders (IND FIL100, n=212; IND FIL200, n=160). Among completers, the reductions in mean partial MCS (pMCS) in SELECTION over weeks zero to ten were maintained up to LTE week 144. High proportions of completers achieved minimal clinically important difference (MCID) in the inflammatory bowel disease questionnaire (IBDQ) score; proportions were maintained over time. No new safety signals were observed over approximately four years of treatment.
The encouraging SELECTION LTE efficacy data pertaining to Jyseleca, coupled with its favourable safety data, could be used to support a regulatory submission for the use of this therapy for the treatment of moderate-to-severe UC in the US; approval for this therapy is anticipated in Q4 2025 on the basis that the MANTA (NCT03201445) study results are sufficient to assure Jyseleca’s testicular safety. On that note, further competition for Jyseleca is provided by Bristol Myers Squibb’s orally administered sphingosine-1 receptor-modulator, Zeposia (ozanimod), which was approved for the same indication in the EU and US in 2021; and AbbVie’s orally administered JAK1 inhibitor Rinvoq (upadacitinib), approved in 2022 in both the US and EU.
If Jyseleca receives approval from the FDA for use in UC, then the agent will inevitably fall behind Zeposia and Rinvoq in terms of its commercial availability in the US. On the other hand, Rinvoq is currently being investigated in a Phase III LTE study (NCT03006068) that is not expected to complete until July 2027. Therefore, Galapagos could leverage Jyseleca’s LTE safety data in UC to gain an advantage over Rinvoq, and aid in increasing physician awareness of Jyseleca in the US.
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Moreover, Galapagos will be keen to focus on Jyseleca’s data in UC since it will likely be the only inflammatory bowel disease (IBD) indication where it will be approved, following the recent negative results from the DIVERSITY (NCT02914561) trial in Crohn’s disease. GlobalData anticipates that Jyseleca will compete directly with Zeposia and Rinvoq and that a head-to-head trial will need to be conducted to differentiate them further.
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