Lilly's Omvoh (mirikizumab-mrkz) approved by U.S. FDA as a single-injection maintenance regimen in adults with ulcerative colitis
Eli Lilly (NYSE: LLY) announced on October 27, 2025 that the U.S. FDA approved a single‑injection, once‑monthly maintenance regimen (200 mg/2 mL) of Omvoh (mirikizumab‑mrkz) for adults with moderately to severely active ulcerative colitis.
The approval follows an EU authorization and is supported by a Phase 1 bioequivalence study comparing one 200 mg/2 mL injection to two 100 mg/1 mL injections. The single‑injection, citrate‑free maintenance dose will be available in the U.S. via prefilled pen or syringe in early 2026. Omvoh retains existing safety warnings for allergic reactions, infections, and liver problems.
Eli Lilly (NYSE: LLY) ha annunciato il 27 ottobre 2025 che la FDA statunitense ha approvato un regime di mantenimento a dose unica, somministrazione mensile (200 mg/2 ml) di Omvoh (mirikizumab-mrkz) per adulti con colite ulcerosa moderatamente‑severa attiva.
L'approvazione segue l'autorizzazione UE ed è supportata da uno studio di bioequivalenza di fase 1 che confronta una singola iniezione da 200 mg/2 ml con due iniezioni da 100 mg/1 ml. La dose di mantenimento a dose unica, priva di citrate, sarà disponibile negli Stati Uniti tramite penna o siringa pre‑riempita all'inizio del 2026. Omvoh mantiene le avvertenze di sicurezza esistenti per reazioni allergiche, infezioni e problemi al fegato.
Eli Lilly (NYSE: LLY) anunció el 27 de octubre de 2025 que la FDA de EE. UU. aprobó un régimen de mantenimiento con una sola inyección, una vez al mes (200 mg/2 mL) de Omvoh (mirikizumab‑mrkz) para adultos con colitis ulcerosa moderadamente a severamente activa.
La aprobación sigue a una autorización de la UE y se apoya en un estudio de bioequivalencia de fase 1 que compara una inyección de 200 mg/2 mL con dos inyecciones de 100 mg/1 mL. La dosis de mantenimiento de una sola inyección, sin citrato, estará disponible en EE. UU. a través de un bolígrafo o jeringa prellenados a principios de 2026. Omvoh mantiene las advertencias de seguridad existentes para reacciones alérgicas, infecciones y problemas hepáticos.
Eli Lilly (NYSE: LLY)가 2025년 10월 27일 미국 식품의약국(FDA)이 성인에서 중등도에서 중증으로 활성화된 궤양성 대장염에 대해 Omvoh( Mirikizumab‑mrkz)의 단일 주사, 매월 유지 요법(200 mg/2 mL)을 승인했다고 발표했습니다.
승인은 EU의 승인을 따른 것이며 1상 생체등가성 연구가 200 mg/2 mL의 단일 주사와 100 mg/1 mL의 두 주사를 비교하는 것을 뒷받침합니다. citrate가 없는 단일 주사 유지 용량은 2026년 초 미국에서 프리필드 펜 또는 주사기로 제공될 예정입니다. Omvoh는 알레르기 반응, 감염 및 간 문제에 대한 기존의 안전 경고를 유지합니다.
Eli Lilly (NYSE: LLY) a annoncé le 27 octobre 2025 que la FDA américaine a approuvé un régime d'entretien par une seule injection, une fois par mois (200 mg/2 mL) d'Omvoh (mirikizumab‑mrkz) pour les adultes atteints d'une colite ulcéreuse active modérée à sévère.
L'approbation fait suite à une autorisation de l'UE et est étayée par une étude de bioéquivalence de phase 1 comparant une injection unique de 200 mg/2 mL à deux injections de 100 mg/1 mL. La dose d'entretien à injection unique, sans citrate, sera disponible aux États‑Unis via stylo ou seringue préremplie au début de 2026. Omvoh conserve les avertissements de sécurité existants concernant les réactions allergiques, les infections et les problèmes hépatiques.
Eli Lilly (NYSE: LLY) gab am 27. Oktober 2025 bekannt, dass die US‑FDA eine einzelne Injektion, monatliche Erhaltungsbehandlung (200 mg/2 ml) von Omvoh (mirikizumab-mrkz) für Erwachsene mit mäßig bis schwer aktivem Colitis ulcerosa genehmigt hat.
Die Zulassung folgt einer EU‑Erlaubnis und wird durch eine Phase‑I‑Bioäquivalenzstudie gestützt, die eine 200 mg/2 ml‑Injektion mit zwei 100 mg/1 ml‑Injektionen vergleicht. Die einzelne, Citrats‑freie Erhaltungsdosis wird in den USA voraussichtlich Anfang 2026 über vorgefüllte Pens oder Spritzen erhältlich sein. Omvoh behält bestehende Sicherheitswarnungen zu allergischen Reaktionen, Infektionen und Leberproblemen bei.
Eli Lilly (NYSE: LLY) أعلنت في 27 أكتوبر 2025 أن إدارة الغذاء والدواء الأمريكية وافقت على بروتوكول صيانة حقنة واحدة، مرة واحدة شهرياً (200 مجم/2 مل) من Omvoh (mirikizumab-mrkz) للبالغين المصابين بالتهاب القولون التقرحي النشط بشكل متوسط إلى شديد.
وتأتي الموافقة عقب ترخيص الاتحاد الأوروبي وتدعمها دراسة نظرية بيولوجية من المرحلة الأولى تقارن حقنة واحدة بجرعة 200 مجم/2 مل باثنتين من الحقن بجرعة 100 مجم/1 مل. ستكون جرعة الصيانة المضافة بجرعة واحدة وخالية من سيترات متاحة في الولايات المتحدة عبر قلم مسبق التعبئة أو محقنة في بداية عام 2026. وOmvoh يحافظ على التحذيرات الأمنية الحالية الخاصة بردود الفعل التحسسية والعدوى ومشاكل الكبد.
Eli Lilly (NYSE: LLY) 于 2025年10月27日 宣布，美国食品药品管理局已批准 Omvoh (mirikizumab-mrkz) 的单次肌注、每月一次的维持方案（200 mg/2 mL），用于成人中等至重度活动性溃疡性结肠炎。
该批准紧随欧洲联盟授权，并有一项1期生物等效性研究支持，比较一针200 mg/2 mL 与两针100 mg/1 mL。单次注射、无柠檬酸的维持剂量将于2026年初在美国通过预装笔或注射器提供。Omvoh 保留对过敏反应、感染和肝脏问题的现有安全警告。
- FDA approval for single‑injection maintenance dosing (200 mg/2 mL)
- Single monthly dose available via prefilled pen or syringe in early 2026
- Phase 1 study confirmed bioequivalence to two‑injection regimen
- Third FDA approval for Omvoh in 2025 (adds to label breadth)
- Omvoh carries serious allergic reaction warnings
- Omvoh may increase risk of infections and requires TB screening
- Omvoh may cause liver problems; monitoring of enzymes required
- Induction requires three IV infusions before switching to maintenance
Insights
FDA approved single‑injection monthly Omvoh for ulcerative colitis; U.S. availability slated for early 2026.
Eli Lilly gains a simpler maintenance formulation of Omvoh for adults with moderately to severely active ulcerative colitis following an FDA approval on
The business effect centers on treatment convenience and delivery complexity reduction for maintenance therapy. Dependencies and risks remain clear and concrete in the disclosure: regulatory status for other regions, the need for induction IV infusions before maintenance, and safety monitoring requirements including infection and liver checks. The release also notes Omvoh already holds approvals for Crohn's disease and a citrate‑free form, and it is approved in 45 countries.
Watchable items and timing: market rollout and patient uptake once distribution begins in
Omvoh now offers patients a simplified maintenance experience with one monthly injection, replacing the previous two-injection regimen
Omvoh single-injection dosing will be available for
This is the third FDA approval for Omvoh this year, following approvals for Crohn's disease and a citrate-free formulation
"In clinical practice, we see that simplifying maintenance treatment can make a difference in the overall patient experience," said Miguel Regueiro, M.D., board-certified gastroenterologist specializing in inflammatory bowel disease. "A single monthly injection of Omvoh gives patients a regimen that's easier to manage alongside the unpredictability of living with ulcerative colitis."
The Omvoh single-injection, citrate-free maintenance dose will be available in the
"People living with the constant discomfort and disruption caused by the symptoms of ulcerative colitis need treatments that offer the potential to achieve lasting remission and a convenient dosing option that fits easily into their lives," said George Salem, M.D., director of Crohn's and Colitis Center at OU HEALTH. "With this approval, patients who respond to induction therapy with Omvoh can continue maintenance therapy with the convenience of just one injection each month — delivering the same proven results with fewer injections."
The single-injection approval is based on results from a Phase 1 study comparing one 200 mg/2 mL subcutaneous injection to two 100 mg/1 mL injections in participants. The study confirmed that Omvoh single-injection is bioequivalent to the previously approved two-injection regimen.1 Treatment with Omvoh for ulcerative colitis starts with 300-mg IV infusions every four weeks, for a total of three infusions, and at Week 12 transitions to subcutaneous self-injection every four weeks for maintenance treatment.
"At Lilly, we are committed to supporting people living with IBD by delivering meaningful clinical outcomes and continuing to improve their treatment experience," said Ashley Diaz-Granados, senior vice president of
Omvoh is approved in the
INDICATIONS AND SAFETY SUMMARY
Omvoh® (ahm-VOH) is a medicine used to treat
- adults with moderately to severely active ulcerative colitis
- adults with moderately to severely active Crohn's disease
It is not known if Omvoh is safe and effective in children under 18 years of age.
Warnings – Omvoh can cause serious side effects including:
Serious allergic reactions: Omvoh may cause serious allergic reactions that may need to be treated in a hospital and may be life-threatening. Do not use Omvoh if you have had a serious allergic reaction to mirikizumab-mrkz or any of the ingredients in Omvoh. See the Medication Guide that comes with Omvoh for a list of ingredients. Stop using Omvoh and get emergency medical help right away if you develop any of the following symptoms of a serious allergic reaction:
- fainting, dizziness, feeling lightheaded
- swelling of your face, eyelids, lips, mouth, tongue, throat, or trouble swallowing
- trouble breathing, throat tightening, or wheezing
- chest tightness
- fast heartbeat or pounding in your chest
- severe itching, hives, or redness all over your body
- sweating
Infections: Omvoh may lower the ability of your immune system to fight infections and may increase your risk of infections. If you have an infection, your healthcare provider should not start treatment with Omvoh until your infection is gone. Before starting treatment with Omvoh, your healthcare provider should assess you for tuberculosis (TB). If you are at risk for TB, you may be treated with medicine for TB before you begin treatment with Omvoh. Your healthcare provider should watch you closely for signs and symptoms of TB while you are being treated with Omvoh and after treatment.
Before starting Omvoh, tell your healthcare provider if you think you have an infection or have symptoms of an infection, such as:
- fever, sweating, or chills
- muscle aches and pain
- cough or shortness of breath
- blood in your mucus (phlegm)
- flu-like symptoms
- headache
- warm, red, or painful skin or sores on your body
- diarrhea or stomach pain
- weight loss
- nausea or vomiting
- pain during urination
After starting Omvoh, tell your healthcare provider right away if you have any symptoms of an infection.
Liver Problems: Omvoh may cause liver problems. Your healthcare provider should do blood tests to check your liver enzyme and bilirubin levels before treatment, during, and after treatment with Omvoh. Your healthcare provider may hold or stop treatment if needed. Tell your healthcare provider right away if you develop any signs and symptoms of liver problems, including:
- unexplained rash
- nausea
- vomiting
- stomach-area (abdominal) pain
- feeling tired
- loss of appetite
- yellowing of the skin or the whites of your eyes
- dark urine
Common side effects
The most common side effects of Omvoh in people treated for ulcerative colitis include:
- upper respiratory infections
- injection site reactions
- joint pain
- rash
- headache
- herpes viral infections
The most common side effects of Omvoh in people treated for Crohn's disease include:
- upper respiratory infections
- injection site reactions
- headache
- joint pain
- elevated liver blood tests
These are not all the possible side effects of Omvoh.
Tell your doctor if you have any side effects. You can report side effects at 1-800-FDA-1088 or www.fda.gov/medwatch.
Before you use Omvoh, review these questions with your doctor:
- Are you being treated for an infection?
- Do you have an infection that does not go away or keeps coming back?
- Do you have TB or have you been in close contact with someone with TB?
- Do you have any possible symptoms of an infection such as fever, chills, muscle aches, cough, shortness of breath, runny nose, sore throat, or pain during urination?
Tell your doctor about all your medical conditions, including if:
- You have a history of serious allergic reaction to Omvoh, any infections or liver problems.
- You need any vaccines or have had one recently. Medicines that interact with the immune system may increase your risk of getting an infection after receiving live vaccines. You should avoid receiving live vaccines right before, during or right after treatment with Omvoh. Tell your healthcare provider that you are taking Omvoh before receiving a vaccine.
- You are pregnant, or plan to become pregnant. It is not known if Omvoh will harm your unborn baby. There will be a pregnancy registry to collect information about women who are exposed to Omvoh during pregnancy. If you become pregnant while taking Omvoh, you are encouraged to report your pregnancy to Eli Lilly and Company at 1-800-545-5979.
- You are breastfeeding or plan to breastfeed. It is not known if Omvoh passes into your breastmilk.
- You take prescription or over-the-counter medicines, vitamins, or herbal supplements.
How to take
Follow your healthcare provider's instructions for using Omvoh. You will receive your first 3 doses of Omvoh through a vein in your arm (intravenous infusion) in a healthcare facility by a healthcare provider every 4 weeks. Each infusion will last about 30 minutes (for ulcerative colitis) or about 90 minutes (for Crohn's disease). After induction, you will continue to receive Omvoh maintenance doses as self-injections under the skin (subcutaneous injection) every 4 weeks. For these injections, Omvoh is available as prefilled pens or prefilled syringes. (If taking Omvoh for Crohn's disease, you will need two injections to complete your dose, using either two prefilled pens or two prefilled syringes.) If you give injections at home, you should be trained on the correct way to prepare and inject Omvoh. Do not try to inject Omvoh yourself until you or your caregiver have been shown how to inject. Read the detailed Instructions for Use about how to use and dispose of Omvoh the correct way.
Learn more
Omvoh is a prescription medicine. During induction, Omvoh is available as a single-dose vial for intravenous infusion containing 300 mg/15 mL that is administered in a healthcare facility.
During maintenance, Omvoh is available as:
- For ulcerative colitis: one 200 mg/2 mL prefilled pen or prefilled syringe.
- For Crohn's disease: one 100 mg/mL prefilled pen or prefilled syringe and one 200 mg/2 mL prefilled pen or prefilled syringe.
For more information, call 1-800-545-5979 or go to omvoh.lilly.com.
This summary provides basic information about Omvoh but does not include all information known about this medicine. Read the information that comes with your prescription each time your prescription is filled. This information does not take the place of talking with your doctor. Be sure to talk to your doctor or other healthcare provider about Omvoh and how to take it. Your doctor is the best person to help you decide if Omvoh is right for you.
MR CON BS 24OCT2025
Omvoh® and its delivery device base are trademarks owned or licensed by Eli Lilly and Company, its subsidiaries, or affiliates.
About Omvoh
Omvoh (mirikizumab-mrkz) is an interleukin-23p19 (IL-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.2
Omvoh and its delivery device base are trademarks owned by Eli Lilly and Company.
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
CMAT-02499 10/2025 © Lilly
Trademarks and Trade Names
All trademarks or trade names referred to in this press release are the property of the company, or, to the extent trademarks or trade names belonging to other companies are references in this press release, the property of their respective owners. Solely for convenience, the trademarks and trade names in this press release are referred to without the ® and ™ symbols, but such references should not be construed as any indicator that the company or, to the extent applicable, their respective owners will not assert, to the fullest extent under applicable law, the company's or their rights thereto. We do not intend the use or display of other companies' trademarks and trade names to imply a relationship with, or endorsement or sponsorship of us by, any other companies.
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 ulcerative colitis and 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 Otani Y, et al. One subcutaneous injection of mirikizumab is bioequivalent to two subcutaneous injections: results from a pharmacokinetic comparability study in healthy participants. 2025 United European Gastroenterology Week. October 4-7, 2025.
2 Omvoh. Prescribing Information. Lilly
Refer to: Kelly Hoffman; kelly.hoffman@lilly.com; 765-736-2555 (Lilly media)
Michael Czapar; czapar_michael_c@lilly.com; 317-617-0983 (Investors)
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SOURCE Eli Lilly and Company
FAQ
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