CHMP recommends Jyseleca to treat moderately to severely active ulcerative colitis.-Galapagos NV.
Following this positive opinion, a final decision from the European Commission is expected later this year.
The CHMP positive opinion is based on data from the pivotal Phase IIb/III SELECTION program, which evaluated filgotinib as an induction and maintenance therapy in adult patients with moderately to severely active UC who have failed conventional therapy or biologics. SELECTION comprised two placebo-controlled induction studies, one in biologic-naive patients and the other in biologic-experienced patients, followed by a 47-week maintenance study for those who responded to filgotinib after 10 weeks. Responders to placebo continued on blinded placebo during the maintenance phase. The trial was recently published in The Lancet.
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