Most patients on Lilly's Omvoh® (mirikizumab-mrkz) for Crohn's disease achieved sustained clinical remission and endoscopic response at two years
Eli Lilly (NYSE: LLY) announced positive two-year results from the VIVID-2 study for Omvoh® (mirikizumab-mrkz) in treating Crohn's disease. The study showed remarkable sustained efficacy, with 92.9% of patients maintaining clinical remission and 87.6% maintaining endoscopic response after two years of continuous treatment.
Among patients not in remission at year one, 60.8% achieved clinical remission and 35.4% gained endoscopic remission during the second year. The safety profile remained consistent, with only 6.8% reporting serious adverse events and 0.8% discontinuing treatment due to adverse events.
Omvoh, which targets IL-23p19 protein to reduce gastrointestinal inflammation, received FDA approval for Crohn's disease in January 2025 and is already approved in 44 countries for ulcerative colitis treatment. It's the first IL-23p19 antagonist demonstrating long-term efficacy for both conditions.
Eli Lilly (NYSE: LLY) ha annunciato risultati positivi dopo due anni dallo studio VIVID-2 per Omvoh® (mirikizumab-mrkz) nel trattamento della malattia di Crohn. Lo studio ha mostrato un'eccezionale efficacia sostenuta, con 92.9% dei pazienti che hanno mantenuto la remissione clinica e 87.6% che hanno mantenuto una risposta endoscopica dopo due anni di trattamento continuo.
Tra i pazienti non in remissione al primo anno, 60.8% ha raggiunto la remissione clinica e 35.4% ha ottenuto la remissione endoscopica durante il secondo anno. Il profilo di sicurezza è rimasto coerente, con solo 6.8% che hanno riportato eventi avversi gravi e 0.8% che hanno interrotto il trattamento a causa di eventi avversi.
Omvoh, che agisce sul proteina IL-23p19 per ridurre l'infiammazione gastrointestinale, ha ricevuto l'approvazione della FDA per la malattia di Crohn a gennaio 2025 ed è già approvato in 44 paesi per il trattamento della colite ulcerosa. È il primo antagonista IL-23p19 a dimostrare un'efficacia a lungo termine per entrambi i disturbi.
Eli Lilly (NYSE: LLY) anunció resultados positivos a dos años del estudio VIVID-2 para Omvoh® (mirikizumab-mrkz) en el tratamiento de la enfermedad de Crohn. El estudio mostró una notable eficacia sostenida, con un 92.9% de los pacientes manteniendo la remisión clínica y un 87.6% manteniendo la respuesta endoscópica después de dos años de tratamiento continuo.
Entre los pacientes que no estaban en remisión al año uno, el 60.8% logró la remisión clínica y el 35.4% logró la remisión endoscópica durante el segundo año. El perfil de seguridad se mantuvo consistente, con solo un 6.8% reportando eventos adversos graves y un 0.8% interrumpiendo el tratamiento debido a eventos adversos.
Omvoh, que se dirige a la proteína IL-23p19 para reducir la inflamación gastrointestinal, recibió la aprobación de la FDA para la enfermedad de Crohn en enero de 2025 y ya está aprobado en 44 países para el tratamiento de la colitis ulcerosa. Es el primer antagonista de IL-23p19 que demuestra eficacia a largo plazo para ambas condiciones.
엘리 릴리 (NYSE: LLY)는 크론병 치료를 위한 Omvoh® (mirikizumab-mrkz)의 VIVID-2 연구에서 2년 긍정적인 결과를 발표했습니다. 이 연구는 놀라운 지속적인 효능을 보여주었으며, 92.9%의 환자가 임상 관해를 유지하고, 87.6%가 2년 연속 치료 후 내시경 반응을 유지했습니다.
1년차에 관해 상태가 아니었던 환자들 중 60.8%가 임상 관해를 달성했고, 35.4%가 두 번째 해에 내시경 관해를 얻었습니다. 안전성 프로필은 일관되게 유지되었으며, 오직 6.8%가 심각한 부작용을 보고했고, 0.8%가 부작용으로 인해 치료를 중단했습니다.
Omvoh는 위장 염증을 줄이기 위해 IL-23p19 단백질을 목표로 하며, 2025년 1월 크론병에 대한 FDA 승인을 받았고, 44개국에서 꾀장염 치료를 위해 이미 승인을 받았습니다. 이는 두 가지 질병 모두에 대해 장기적인 효능을 입증한 처음의 IL-23p19 길항제입니다.
Eli Lilly (NYSE: LLY) a annoncé des résultats positifs après deux ans de l'étude VIVID-2 pour Omvoh® (mirikizumab-mrkz) dans le traitement de la maladie de Crohn. L'étude a montré une efficacité soutenue remarquable, avec 92.9% des patients maintenant une rémission clinique et 87.6% maintenant une réponse endoscopique après deux ans de traitement continu.
Parmi les patients non en rémission à la première année, 60.8% ont atteint une rémission clinique et 35.4% ont obtenu une rémission endoscopique durant la deuxième année. Le profil de sécurité est resté cohérent, avec seulement 6.8% rapportant des événements indésirables graves et 0.8% interrompant le traitement en raison d'événements indésirables.
Omvoh, qui cible la protéine IL-23p19 pour réduire l'inflammation gastro-intestinale, a reçu l'approbation de la FDA pour la maladie de Crohn en janvier 2025 et est déjà approuvé dans 44 pays pour le traitement de la colite ulcéreuse. C'est le premier antagoniste de l'IL-23p19 à démontrer une efficacité à long terme pour les deux conditions.
Eli Lilly (NYSE: LLY) gab positive Ergebnisse nach zwei Jahren aus der VIVID-2-Studie für Omvoh® (mirikizumab-mrkz) zur Behandlung der Morbus Crohn bekannt. Die Studie zeigte eine bemerkenswerte nachhaltige Wirksamkeit, mit 92.9% der Patienten, die eine klinische Remission aufrechterhielten, und 87.6%, die nach zwei Jahren kontinuierlicher Behandlung eine endoskopische Antwort behielten.
Unter den Patienten, die im ersten Jahr keine Remission hatten, erreichten 60.8% eine klinische Remission und 35.4% erreichten während des zweiten Jahres eine endoskopische Remission. Das Sicherheitsprofil blieb konstant, mit nur 6.8%, die über schwerwiegende unerwünschte Ereignisse berichteten, und 0.8% die die Behandlung aufgrund von unerwünschten Ereignissen abbrachen.
Omvoh, das auf das IL-23p19-Protein abzielt, um die gastrointestinalen Entzündungen zu reduzieren, erhielt im Januar 2025 die FDA-Zulassung für Morbus Crohn und ist bereits in 44 Ländern zur Behandlung von Colitis ulcerosa zugelassen. Es ist der erste IL-23p19-Antagonist, der eine langfristige Wirksamkeit für beide Erkrankungen zeigt.
- 92.9% of patients maintained clinical remission at two years
- 87.6% maintained endoscopic response after two years
- 60.8% of non-remission patients achieved clinical remission in second year
- Recent FDA approval for Crohn's disease treatment (January 2025)
- Strong safety profile with only 0.8% treatment discontinuation rate
- None.
Insights
The latest data from Eli Lilly's VIVID-2 study represents a significant breakthrough in inflammatory bowel disease treatment. The 92.9% clinical remission maintenance rate and 87.6% endoscopic response maintenance at two years are exceptional outcomes in the challenging landscape of Crohn's disease management.
The IL-23p19 targeting mechanism of Omvoh is particularly noteworthy, as it offers a more selective approach compared to broader immunosuppressive treatments. This specificity likely contributes to the strong efficacy-safety balance observed in the study. The 60.8% new clinical remission rate in previously non-responding patients during the second year suggests potential cumulative benefits with continued treatment.
From a market perspective, Omvoh's position as the first IL-23p19 antagonist approved for both Crohn's disease and ulcerative colitis creates a unique competitive advantage. The drug's recent FDA approval, combined with these robust long-term data and pending global regulatory decisions, positions it strongly in the $20+ billion inflammatory bowel disease market. The low discontinuation rate of 0.8% due to adverse events further strengthens its commercial potential.
The ongoing pediatric studies and real-world evidence collection demonstrate Lilly's commitment to expanding Omvoh's clinical utility. This comprehensive development program, coupled with the drug's proven efficacy in biologic-failure patients, suggests significant market penetration potential in both first-line and refractory disease settings.
More than
Nearly
Omvoh is the first IL-23p19 antagonist to demonstrate multi-year, sustained efficacy and safety for both Crohn's disease and ulcerative colitis
Omvoh works to reduce inflammation within the gastrointestinal tract by targeting a specific protein, interleukin-23p19 (IL-23p19), which is a key contributor to intestinal inflammation.2,3
"Many people living with Crohn's disease have tried available therapies without success or have experienced a loss of efficacy with their treatment," said Edward Barnes, M.D., MPH, Associate Professor of Medicine in the Division of Gastroenterology & Hepatology, Co-Director of the Multidisciplinary Inflammatory Bowel Diseases Center at the University of
Participants randomized to Omvoh in the Phase 3 VIVID-1 study who achieved endoscopic response after one year of treatment continued Omvoh maintenance treatment in VIVID-2. The following results were achieved based upon observed case analysis after two years of continuous treatment, including one year during VIVID-1:
- Among patients who were in clinical remission at one year in VIVID-1,
92.9% maintained clinical remission at two years as measured by Crohn's Disease Activity Index (CDAI). - Among patients treated in VIVID-2,
87.6% maintained endoscopic response, defined by visible healing of the intestinal lining and measured by a ≥50% reduction from baseline in Simple Endoscopic Score for Crohn's Disease (SES-CD) total score. - Among patients who were in endoscopic remission at one year of treatment in VIVID-1,
78.6% maintained endoscopic remission at two years as measured by SES-CD ≤4 and ≥2-point reduction from baseline, with no subscore >1 in any individual variable.1
Additionally:
- Among patients who were not in clinical remission by CDAI at one year,
60.8% gained clinical remission during the second year of treatment. - Among patients who were not in endoscopic remission at one year,
35.4% gained endoscopic remission during the second year of treatment.1
These results were also evaluated using a modified non-responder imputation method, presented in the About the VIVID Clinical Trial Program section below.
In VIVID-2, the long-term safety profile of Omvoh in patients with moderately to severely active Crohn's disease was generally consistent with the known safety profile of Omvoh. During the second year of continuous treatment with Omvoh,
"Lilly is setting a high bar for sustained and durable treatment response for patients living with the profound impact of inflammatory bowel disease," said Mark Genovese, M.D., senior vice president of Lilly Immunology development. "These results build on the body of evidence that demonstrates Omvoh's ability to provide early meaningful improvement and long-term disease control with strong clinical, endoscopic and histologic outcomes."
Omvoh was approved by the United States Food and Drug Administration (FDA) for the treatment of moderately to severely active Crohn's disease in adults in January 2025. In December 2024, the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion for Omvoh for the treatment of adults with moderately to severely active Crohn's disease. Lilly has submitted marketing applications around the globe, including in Canada, Japan and China, with additional global regulatory submissions planned. Omvoh is also approved in 44 countries for the treatment of moderately to severely active ulcerative colitis (UC) in adults.
Omvoh is the first and only IL-23p19 antagonist to demonstrate long-term, multi-year, sustained efficacy and safety for both Crohn's disease and UC.
Omvoh has additional ongoing trials in Crohn's disease and UC, including studies to evaluate the long-term efficacy and safety of Omvoh in pediatric patients and adults, and a Phase 4 real-world evidence study to evaluate Omvoh's impact in patients with UC in clinical practice.
About the VIVID Clinical Trial Program
VIVID-1 was a Phase 3 randomized, double-blind, placebo-controlled 52-week study in adults with moderately to severely active Crohn's disease. Patients randomized to Omvoh received Omvoh 900mg by intravenous (IV) infusion at Week 0, Week 4 and Week 8 followed by a maintenance dose of 300mg by subcutaneous injection (SC) at Week 12 and then every 4 weeks (Q4W) for 40 weeks.2
Participants who completed VIVID-1, including the Week 52 endoscopy, were eligible for VIVID-2. In VIVID-2, the primary objective is to evaluate the long-term effect of Omvoh in clinical remission by CDAI and endoscopic response at Week 52 of treatment in VIVID-2 (totaling 104 weeks of continuous treatment). Safety is being assessed from the first dose in VIVID-2.1
Using a modified non-responder imputation method, among Omvoh endoscopic responders at year one,
About Omvoh®
Omvoh® (mirikizumab-mkrz) is an interleukin-23p19 antagonist indicated for the treatment of moderately to severely active ulcerative colitis and Crohn's disease in adults. Omvoh selectively targets the p19 subunit of IL-23 and inhibits the IL-23 pathway. Inflammation due to over-activation of the IL-23 pathway plays a critical role in the pathogenesis of inflammatory bowel disease.4
Omvoh® and its delivery device base are trademarks owned by Eli Lilly and Company.
Indications and Usage for Omvoh® (mirikizumab-mrkz) (in
Omvoh is an interleukin-23 antagonist indicated for adults with:
- Moderately to severely active ulcerative colitis
- Moderately to severely active Crohn's disease
Important Safety Information for Omvoh (mirikizumab-mrkz)
CONTRAINDICATIONS
Omvoh is contraindicated in patients with a history of serious hypersensitivity reaction to mirikizumab-mrkz or any of the excipients.
WARNINGS AND PRECAUTIONS
Hypersensitivity Reactions
Serious hypersensitivity reactions, including anaphylaxis during intravenous infusion, have been reported with Omvoh administration. Infusion-related hypersensitivity reactions, including mucocutaneous erythema and pruritus, were reported during induction. If a severe hypersensitivity reaction occurs, discontinue Omvoh immediately and initiate appropriate treatment.
Infections
Omvoh may increase the risk of infection. Do not initiate treatment with Omvoh in patients with a clinically important active infection until the infection resolves or is adequately treated. In patients with a chronic infection or a history of recurrent infection, consider the risks and benefits prior to prescribing Omvoh. Instruct patients to seek medical advice if signs or symptoms of clinically important acute or chronic infection occur. If a serious infection develops or an infection is not responding to standard therapy, monitor the patient closely and do not administer Omvoh until the infection resolves.
Tuberculosis
Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with Omvoh. Do not administer Omvoh to patients with active TB infection. Initiate treatment of latent TB prior to administering Omvoh. Consider anti-TB therapy prior to initiation of Omvoh in patients with a history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Monitor patients for signs and symptoms of active TB during and after Omvoh treatment. In clinical trials, subjects were excluded if they had evidence of active TB, a history of active TB, or were diagnosed with latent TB at screening.
Hepatotoxicity
Drug-induced liver injury in conjunction with pruritus was reported in a clinical trial subject following a longer than recommended induction regimen. Omvoh was discontinued. Liver test abnormalities eventually returned to baseline. Evaluate liver enzymes and bilirubin at baseline and for at least 24 weeks of treatment. Monitor thereafter according to routine patient management. Consider other treatment options in patients with evidence of liver cirrhosis. Prompt investigation of the cause of liver enzyme elevation is recommended to identify potential cases of drug-induced liver injury. Interrupt treatment if drug-induced liver injury is suspected, until this diagnosis is excluded. Instruct patients to seek immediate medical attention if they experience symptoms suggestive of hepatic dysfunction.
Immunizations
Avoid use of live vaccines in patients treated with Omvoh. Medications that interact with the immune system may increase the risk of infection following administration of live vaccines. Prior to initiating therapy, complete all age-appropriate vaccinations according to current immunization guidelines. No data are available on the response to live or non-live vaccines in patients treated with Omvoh.
ADVERSE REACTIONS
Most common adverse reactions associated with Omvoh (≥
Omvoh injection is available as a 300 mg/15 mL solution in a single-dose vial for intravenous infusion, and as a 100 mg/mL solution or a 200 mg/2 mL solution in a single dose prefilled pen or prefilled syringe for subcutaneous injection. Refer to the Prescribing Information for dosing information.
MR HCP ISI CD APP
Click to access provided Prescribing Information and Medication Guide. See Instructions for Use provided with the device.
About Lilly
Lilly is a medicine company turning science into healing to make life better for people around the world. We've been pioneering life-changing discoveries for nearly 150 years, and today our medicines help tens of millions of people across the globe. Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world's most significant health challenges: redefining diabetes care; treating obesity and curtailing its most devastating long-term effects; advancing the fight against Alzheimer's disease; providing solutions to some of the most debilitating immune system disorders; and transforming the most difficult-to-treat cancers into manageable diseases. With each step toward a healthier world, we're motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable. To learn more, visit Lilly.com and Lilly.com/news, or follow us on Facebook, Instagram, and LinkedIn. P-LLY
Cautionary Statement Regarding Forward-Looking Statements
This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about Omvoh (mirikizumab-mrkz) as a treatment for people with moderate to severe Crohn's disease and reflects Lilly's current beliefs and expectations. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of drug research, development, and commercialization. Among other things, there is no guarantee that planned or ongoing studies will be completed as planned, that future study results will be consistent with study results to date, that Omvoh will receive additional regulatory approvals, or that Omvoh will be commercially successful. For further discussion of these and other risks and uncertainties that could cause actual results to differ from Lilly's expectations, see Lilly's Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly undertakes no duty to update forward-looking statements to reflect events after the date of this release.
References
1 Barnes, EL, et al. Long-term efficacy and safety of mirikizumab following 104 weeks of continuous treatment for Crohn's Disease: results from the VIVID-2 open-label extension study. 2025 Crohn's and Colitis Congress. February 6-8, 2025.
2 Ferrante M, et al. Efficacy and safety of mirikizumab in patients with moderately-to-severely active Crohn's disease: a phase 3, multicentre, randomised, double-blind, placebo-controlled and active-controlled, treat-through study. The Lancet. 2024;404(10470):2423-2436.
3 Chang JT. Pathophysiology of inflammatory bowel diseases. N Engl J Med. 2020 Dec 31;383(27):2652-2664. doi: 10.1056/NEJMra2002697. PMID: 33382932.
4 Omvoh. Prescribing Information. Lilly
Refer to: | Kathleen Ritchie; kathleen.ritchie@lilly.com; 562-323-1667 (Lilly media) |
Michael Czapar; czapar_michael_c@lilly.com; 317-617-0983 (Investors) |
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