Shots:
- Health Canada has approved Omvoh to treat mod. to sev. active Crohn’s disease (CD) unresponsive/intolerant to conventional or biologic therapy along with its new citrate-free formulation for SC use in both UC & CD
- Approval was based on P-III (VIVID-1) trial of Omvoh (900mg, IV, wks.0, 4, 8 then 300mg, SC, Q4W from wks.12-52; n= 579) vs PBO (n=199) & Stelara in ~1000 CD pts
- Trial met its coprimary composite endpoints incl. PRO clinical response at Wk. 12 with endoscopic response at Wk. 52 (38% vs 9%) & PRO clinical response at Wk. 12 with CDAI remission at Wk. 52 (45% vs 20%), along with meeting all of its 2EPs; consistent results were seen in subgroups regardless of prior biologic failure
Ref: Newswire| Image: Eli Lilly | Press Release
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