Shots:
- The CHMP grants a positive opinion to Skyrizi for treating moderate to severely active UC in adults with inadequate or lost response and were intolerant to conventional or biologic therapy. Final decision is anticipated in Q3’24
- The positive opinion was based on the P-III (INSPIRE) study, assessing Skyrizi (induction treatment: 1200mg, IV, 0,4 & 8wks.) in moderate to severely active UC patients, and P-III (COMMAND) study, evaluating Skyrizi (180mg/360mg, SC, another 52wks.) in patients who responded to induction treatment
- The two studies met the 1EP of clinical remission & 2EPs of endoscopic improvement and histologic-endoscopic mucosal improvement and showed consistent safety profiles without any new risks
Ref: Abbvie | Image: Abbvie | Press Release
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