Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 96 |
| INN | Mirikizumab |
| Status | Approved |
| Drug code(s) | LY3074828 |
| Brand name | Omvoh |
| mAb sequence source | mAb humanized |
| General Molecular Category | Naked monospecific |
| Format, general category | Full length Ab |
| Format details | None |
| Isotype (Fc) | IgG4 |
| Light chain isotype | kappa |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | None |
| Target(s) | IL-23p19 |
| Indications of clinical studies | Ulcerative colitis, psoriasis, Crohn's disease |
| Primary therapeutic area | Immune-mediated / inflammatory disorders |
| Most advanced stage of development (global) | Approved EU, US, Japan, Australia, UK, Canada |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | October 15, 2013 |
| Start of Phase 2 | December 15, 2015 |
| Start of Phase 3 | April 24, 2018 |
| Date BLA/NDA submitted to FDA | March 30, 2022 |
| Year of first approval (global) | 2023 |
| Date of first US approval | October 26, 2023 |
| INN, US product name | Mirikizumab, mirikizumab-mrkz |
| US or EU approved indications | US: Omvoh™ (mirikizumab-mrkz) infusion (300 mg/15 mL)/injection (100 mg/mL) approved for the treatment of moderately to severely active ulcerative colitis (UC) in adults. EU: Treatment of moderately to severely active ulcerative colitis |
| Company | Eli Lilly and Company |
| Licensee/Partner | None |
| Comments about company or candidate | Apr 2024: Submission of mirikizumab for the treatment of adults with moderately to severely active Crohn's disease in the U.S. and EU. https://investor.lilly.com/news-releases/news-release-details/lilly-reports-first-quarter-2024-financial-results-and-raises Oct. 26, 2023: Eli Lilly and Company (NYSE: LLY) announced today that the U.S. Food and Drug Administration (FDA) has approved Omvoh™ (mirikizumab-mrkz) infusion (300 mg/15 mL)/injection (100 mg/mL), the first and only interleukin-23p19 (IL-23p19) antagonist for the treatment of moderately to severely active ulcerative colitis (UC) in adults. Oct 2023: Mirikizumab (Omvoh) met the co-primary and all major secondary endpoints compared to placebo in VIVID-1, a Phase 3 study evaluating the safety and efficacy of mirikizumab for the treatment of adults with moderately to severely active Crohn's disease. Lilly plans to submit a marketing application for mirikizumab in Crohn's disease to the FDA, followed by submissions to other regulatory agencies around the world, in 2024. Apr 13, 2023: Eli Lilly and Company announced the U.S. Food and Drug Administration has issued a complete response letter for the mirikizumab biologic license application for the treatment of ulcerative colitis (UC). In the letter, the FDA cited issues related to the proposed manufacturing of mirikizumab, with no concerns about the clinical data package, safety, or label for the medicine Approved in the EU May 26, 2023 Mar 30, 2023: Omvoh (mirikizumab) received a positive opinion from the CHMP for the treatment of moderately to severely active ulcerative colitis, an inflammation of the large intestine causing ulceration and bleeding. Expect EC decision in 67 days BLA submitted in Q1 2022; EMA evaluation started May 19, 2022. Japan’s health ministry approved a raft of new medicines and indications on March 27, 2023 including Eli Lilly’s ulcerative colitis med Omvoh (mirikizumab). Dec 2021: Mirikizumab demonstrates superiority over placebo in phase 3 maintenance study in ulcerative colitis, supporting regulatory submissions in 2022 Lilly announced in April 2021 that they do not plan to pursue submission in psoriasis. July 17, 2020 I Eli Lilly and Company (NYSE:LLY) announced today that mirikizumab, an investigational monoclonal antibody that binds to the p19-subunit of IL23, met the primary and all key secondary endpoints versus placebo at Week 16 (superiority) and all key secondary endpoints versus Cosentyx (secukinumab) at Week 16 (non-inferiority) and Week 52 (superiority) in the OASIS-2 study. May 21, 2019: In an oral presentation from the Digestive Disease Week medical conference in San Diego, California today, Eli Lilly and Company announced new safety and efficacy data for mirikizumab in patients with moderately- to severely active Crohn's disease. Patients treated with mirikizumab in the SERENITY Phase 2 study achieved significant reductions in clinical and endoscopic measures of disease activity at 12 weeks compared to placebo. The maintenance phase of this study is ongoing. NCT03926130 Phase 3 in CD started recruiting in July 2019. Four Phase 3 studies in UC and psoriasis recruiting as of July 2018. June 2018: Abstract entitled "Efficacy and Safety of Anti-Interleukin-23 Therapy with Mirikizumab (LY3074828) in Patients with Moderate-to-Severe Ulcerative Colitis in a Phase 2 Study" presented at the Digestive Disease Week (DDW) on June 5, 2018. Mirikizumab demonstrated efficacy in the induction treatment for patients with moderate-to-severe UC, as assessed by multiple measures. NCT02589665 Phase 2 study in ulcerative colitis recruiting as of April 2016. Phase 1 NCT01947933 started in Oct 2013, completed as of Aug 2014 |
| Full address of company | Indianapolis, Indiana, United States North America United States of America https://www.lilly.com/contact-us |
S228P (hinge-stabilization), F234A, L235A (impair Fc effector function)
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |