Following the news that Galapagos presented new efficacy and safety data of Jyseleca (filgotinib) 200mg (FIL200) therapy for the treatment of patients with ulcerative colitis (UC) being assessed in the continuing SELECTION long term extension (LTE) study:

Ramla Salad, Pharma Analyst at GlobalData, a leading data and analytics company, offers her view: “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. According to GlobalData estimates, the 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.

“Jyseleca is expected to be the third JAK inhibitor to enter the US market behind two other JAK inhibitors- AbbVie’s Rinvoq (upadacitinib) and Pfizer’s Xeljanz (tofacitinib). Given Jyseleca’s later timeline of entry, Galapagos could leverage the latest LTE safety data in UC to build up the therapy’s position in a crowded market, as well as aid in increasing physician awareness of Jyseleca in the US.

“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, given its recent setback with a pivotal study in Crohn’s disease.”