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 2026Approval 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…
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 treatmentIn LUCENT-3, among pts who achieved clinical remission with Omvoh at 1yr.…
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 & CDApproval was based on P-III (VIVID-1) trial of Omvoh (900mg, IV, wks.0, 4, 8 then 300mg, SC, Q4W from wks.12-52;…
Shots: Lilly presented results from two long-term studies evaluating sustained efficacy in patients treated with mirikizumab for both moderately to severely active Ulcerative Colitis and Crohn’s Disease at ACG 2024 At three years, more than 80 percent of patients with moderately to severely active ulcerative colitis who were on remission sustained long-term remission and relief …
Shots: Recently, at UEGW 2024, Lilly presented histologic and combined histologic-endoscopic outcomes from the VIVID-1 Phase III study, which evaluated the safety and efficacy of mirikizumab in adults with moderately to severely active Crohn’s disease A key finding reported during UEG Week highlighted the interactions between mirikizumab and ustekinumab, particularly regarding histologic response and remission,…
Shots: Dr. Lotus Mallbris shares the positive endpoint results of the VIVID-1 P-III study, evaluating the safety and efficacy of mirikizumab for the treatment of adults with moderately to severely active Crohn’s disease While shedding light on the mechanism of mirkizumab, Lotus highlights that available therapies to treat Crohn’s disease often fail to achieve clinical…
In a recent interview with PharmaShots, Dr. Lotus Mallbris, the Vice President of Immunology Development at Eli Lilly shares her insights and highlights on Mirikizumab. Shots:@52wks. ~60% achieved endoscopic responses (58.5% in IV dosing group and 58.7% in the SC group) while 45% + achieved PRO remission (46.3% in the IV group and 45.6% in the SC…

