Eli Lilly’ Omvoh (mirikizumab-mrkz) Receives the US FDA’s Approval for Adults with Moderately to Severely Active Ulcerative Colitis
Shots:
- The approval was based on the (LUCENT) program incl. 2 P-III trials i.e., one 12wk. induction study (UC-1) and one 40wk. maintenance study (UC-2) for 52wks.
- In (UC-1 & 2) trials, clinical remission (24% vs 15% & 51% vs 27%), endoscopic improvement (34% vs 21% & 58% vs 30%); histologic-endoscopic mucosal improvement (25% vs 14% & 43% vs 22%), clinical response (65% vs 43%) in (UC 1), (51% vs 27%) of all patients and 45% vs 15% who failed prior treatment with a biologic or JAKi achieved clinical remission at 1yr., improvement of symptoms i.e., rectal bleeding & stool frequency were seen as early as three weeks
- In (UC2), steroid-free clinical remission (50% vs 27%) at 1yr. who achieved clinical response at 12wks. In a post-hoc analysis, 99% were steroid-free, and 66% vs 40% maintained clinical remission. The product will be available in the US in the coming weeks
Ref: PR Newswire | Image: Eli Lilly
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