Shots:

• The P-III trial (DIVERSITY) evaluating filgotinib (100/200mg, qd) vs PBO as induction & maintenance treatment in 1374 biologic-naïve & biologic-experienced patients
• Both induction cohorts of the study failed to meet the co-primary EPs of clinical remission & endoscopic response for filgotinib. In the maintenance phase, patients treated with filgotinib (200mg, qd) achieved the co-primary 1EPs of clinical remission (43.8% vs 26.4%) & endoscopic response (30.4% vs 9.4%) @58wk. & the safety profile was consistent with prior studies' results across indications
• The company has decided not to submit an MAA in the EU, based on these results & plans to initiate a P-III study for AxSpA, expected in 2023. Filgotinib is marketed as Jyseleca in the EU & Japan for active RA & UC

Ref: Globe Newswire | Image: Galapagos

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