Eli Lilly and Company (NYSE: LLY) announced today that the(FDA) approved a single-injection, once-monthly maintenance regimen (200 mg/2 mL) of Omvoh (mirikizumab-mrkz) for subcutaneous use in adults with moderately to severely active ulcerative colitis (UC).

礼来公司(NYSE: LLY) 今天宣布美国食品药品监督管理局（FDA）批准了Omvoh（mirikizumab-mrkz）的单次注射、每月一次维持方案（200 mg/2 mL），用于中度至重度活动性溃疡性结肠炎（UC）成年患者的皮下注射。

'In clinical practice, we see that simplifying maintenance treatment can make a difference in the overall patient experience,' said

“在临床实践中，我们看到简化维持治疗可以改善患者的总体体验，”

Miguel Regueiro

米格尔·雷格罗

, 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.'

，医学博士，经委员会认证的胃肠病学家，专门研究炎症性肠病。“每月单次注射Omvoh为患者提供了一种更容易管理的方案，以应对溃疡性结肠炎带来的不可预测性。”

The Omvoh single-injection, citrate-free maintenance dose will be available in the

Omvoh 单次注射、无柠檬酸盐的维持剂量将会提供在

U.S.

美国

via prefilled pen or prefilled syringe in early 2026. The

通过预填充笔或预填充注射器在2026年初使用。

U.S.

美国

approval follows the recent

批准紧随最近的

European Union

欧盟

authorization of Omvoh for single-injection maintenance dosing for UC.

授权Omvoh用于UC的单次注射维持剂量。

'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

“生活在溃疡性结肠炎症状引起的持续不适和干扰中的人们需要这样的治疗：有潜力实现持久缓解，并且剂量方案便捷，能够轻松融入他们的生活，”

George Salem

乔治·塞勒姆

, 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.'

医学博士，OU HEALTH克罗恩病和结肠炎中心主任表示：“随着这一批准，对Omvoh诱导治疗有反应的患者可以继续进行维持治疗，每月只需注射一次，即可获得同样经过验证的效果，且注射次数更少。”

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.

单次注射的批准是基于一项 1 期研究的结果，该研究比较了参与者单次 200 mg/2 mL 皮下注射与两次 100 mg/1 mL 注射的效果。研究证实，Omvoh 单次注射与之前批准的两次注射方案具有生物等效性。

About Omvoh

关于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..

Omvoh（mirikizumab-mrkz）是一种白细胞介素-23p19（IL-23p19）拮抗剂，用于治疗中度至重度活动性溃疡性结肠炎和成人克罗恩病。Omvoh选择性靶向IL-23的p19亚基并抑制IL-23通路。IL-23通路的过度激活引起的炎症在炎症性肠病的发病机制中起着关键作用。

About Lilly

关于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.

礼来是一家医药公司，将科学转化为治疗手段，以改善世界各地人们的生活。近150年来，我们一直在开创改变生命的发现，如今我们的药物帮助了全球数千万人。通过利用生物技术、化学和基因医学的力量，我们的科学家正在迅速推进新的发现，以解决一些全球最重要的健康挑战：重新定义糖尿病护理；治疗肥胖症并遏制其最具破坏性的长期影响；推动对抗阿尔茨海默病的斗争；为一些最严重的免疫系统疾病提供解决方案；并将最难治疗的癌症转化为可控制的疾病。

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 .

每迈向更健康的世界一步，我们都受到一个目标的驱动：让数百万人的生活更美好。这包括开展反映世界多样性的创新临床试验，并努力确保我们的药品可及且负担得起。欲了解更多信息，请访问。