Eli Lilly’s Omvoh (mirikizumab-mrkz) Receives the US FDA’s Approval for Ulcerative Colitis

Shots: The US FDA has approved Omvoh (200mg/2mL, SC, QM) as a maintenance treatment of adults with mod. to sev. active ulcerative colitis; PFS & prefilled pen to be available in early 2026 Approval was based on P-I trial assessing Omvoh (200mg/2mL, SC) single injection vs 2 100mg/1mL injections in participants, which showed bioequivalence between the…

ByDipanshu DixitOctober 28, 2025

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Eli Lilly Reports P-III (LUCENT-3) OLE Trial Data of Omvoh to Treat Ulcerative Colitis

Shots: Eli Lilly has reported long-term data from the P-III (LUCENT-3) OLE study of P-III (LUCENT-1 & LUCENT-2) trials, evaluating the efficacy & safety of Omvoh (mirikizumab-mrkz) in mod. to sev. active ulcerative colitis pts over an additional 3yrs., totaling ~4yrs. of treatment In LUCENT-3, among pts who achieved clinical remission with Omvoh at 1yr.…

ByRidhi RastogiOctober 8, 2025

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Eli Lilly Receives the Health Canada’s Approval for Omvoh (Mirikizumab) to Treat Crohn’s Disease (CD)

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;…

ByRidhi RastogiJuly 16, 2025

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Eli Lilly Reveals VIVID-2 Study Data of Omvoh to Treat Crohn’s Disease

Shots: Eli Lilly has reported 2yrs. data from VIVID-2 (OLE) study (incl. 1yr. of VIVID-1) of Omvoh for mod. to sev. Crohn's disease; regulatory review is underway in China, Canada, Japan & other regions In VIVID-1, 92.9% pts sustained clinical remission (CDAI) and 78.6% retained endoscopic remission (SES-CD ≤4 & ≥2-point decrease, with no…

ByRidhi RastogiFebruary 10, 2025

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Eli Lilly Receives the US FDA’s Approval for Omvoh (Mirikizumab-mrkz) to Treat Crohn’s Disease (CD)

Shots: Approval was based on a P-III (VIVID-1) trial assessing Omvoh vs PBO in mod. to sev. CD patients, unresponsive/intolerable to corticosteroids, BRMs &/or biologics, post its approval for UC in Dec 2023. Regulatory submissions are filed globally, incl. Japan & the EU, with other submissions underway Study showed 53% vs 36% clinical remission &…

ByRidhi RastogiJanuary 16, 2025

Eli Lilly’s Omvoh (mirikizumab-mrkz) Receives the US FDA’s Approval for Ulcerative Colitis

Eli Lilly Reports P-III (LUCENT-3) OLE Trial Data of Omvoh to Treat Ulcerative Colitis

Eli Lilly Receives the Health Canada’s Approval for Omvoh (Mirikizumab) to Treat Crohn’s Disease (CD)

Eli Lilly Reveals VIVID-2 Study Data of Omvoh to Treat Crohn’s Disease

Eli Lilly Receives the US FDA’s Approval for Omvoh (Mirikizumab-mrkz) to Treat Crohn’s Disease (CD)

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