Omvoh achieved primary and key secondary endpoints, including sustained clinical remission in pivotal trials

Omvoh达到了主要和关键的次要终点，包括关键试验中的持续临床缓解

Omvoh delivered significant improvement in bowel urgency, reported by people with UC as one of the most disruptive symptoms

据UC患者报告，Omvoh显着改善了肠道紧迫性，这是最具破坏性的症状之一

Lilly's first approved treatment for a type of inflammatory bowel disease

礼来公司首次批准用于治疗一种炎症性肠病

INDIANAPOLIS, Oct. 26, 2023 /PRNewswire/ -- 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..

2023年10月26日，印第安纳波利斯/PRNewswire/-礼来公司（纽约州：LLY）今天宣布，美国食品和药物管理局（FDA）已批准Omvoh™ （mirikizumab mrkz）输注（300 mg/15 mL）/注射（100 mg/mL），第一种也是唯一一种用于治疗中度至重度活动性溃疡性结肠炎（UC）的白细胞介素-23p19（IL-23p19）拮抗剂成人。。

Marking a significant milestone, Omvoh is the only UC treatment that selectively targets the p19 subunit of IL-23, which plays a role in inflammation related to UC.

标志着一个重要的里程碑，Omvoh是唯一选择性靶向IL-23 p19亚基的UC治疗，IL-23在与UC相关的炎症中发挥作用。

'I see many people with ulcerative colitis who previously tried other biologic treatments, and they are still searching for an effective option that can offer rapid and lasting improvements,' said Bruce Sands, M.D., M.S., Dr. Burrill B. Crohn Professor of Medicine and Chief of the Dr. Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai.

“我看到许多溃疡性结肠炎患者以前曾尝试过其他生物治疗，他们仍在寻找能够提供快速持久改善的有效选择，”医学博士Bruce Sands博士，医学博士Burrill B.Crohn博士和西奈山伊坎医学院消化内科主任Henry D.Janowitz博士说。

'Today's approval represents a novel scientific advancement, providing a treatment that may offer relief from three key symptoms—stool frequency, rectal bleeding and bowel urgency—regardless of past biologic use.'.

“今天的批准代表了一种新的科学进步，提供了一种治疗方法，可以缓解三种主要症状-大便次数，直肠出血和肠道紧急情况-无论过去的生物用途如何。”。

The approval was based on results from the LUCENT program, which included two randomized, double-blind, placebo-controlled Phase 3 clinical trials consisting of one 12-week induction study (UC-1) and one 40-week maintenance study (UC-2) for 52 weeks of continuous treatment. All patients in the LUCENT program had past treatments, including biologic treatments, that did not work, stopped working or that they could not tolerate..

该批准基于LUCENT计划的结果，其中包括两项随机，双盲，安慰剂对照的3期临床试验，包括一项为期12周的诱导研究（UC-1）和一项为期40周的维持研究（UC-2））持续治疗52周。LUCENT项目中的所有患者都有过去的治疗方法，包括生物治疗，这些治疗方法不起作用，停止工作或无法忍受。。

After 12 weeks of treatment with Omvoh, nearly two-thirds (65%) of patients achieved clinical response and nearly one-fourth (24%) achieved clinical remission compared to placebo (43% and 15%, for clinical response and clinical remission, respectively). Among those who achieved clinical response at 12 weeks, Omvoh demonstrated consistent efficacy across subgroups, with 51% of all patients and 45% of patients who failed prior treatment with a biologic or Janus kinase inhibitor (JAKi) achieving clinical remission at one year compared to placebo (27% and 15%, respectively).

Omvoh治疗12周后，与安慰剂相比，近三分之二（65%）的患者达到临床反应，近四分之一（24%）达到临床缓解（43%和15%，临床反应和临床缓解，分别）。在12周时达到临床反应的患者中，Omvoh在各亚组中表现出一致的疗效，51%的患者和45%的先前用生物或Janus激酶抑制剂（JAKi）治疗失败的患者在一年内达到临床缓解安慰剂（分别为27%和15%）。

Among those who achieved clinical response at 12 weeks, one-half (50%) achieved steroid-free clinical remission at one year, compared to placebo (27%). Per a post-hoc analysis, nearly all patients (99%) who achieved clinical remission at one year were steroid-free. Patients in steroid-free clinical remission were steroid-free for at least three months prior to the end of the 52-week assessment.

在12周达到临床反应的患者中，与安慰剂（27%）相比，一半（50%）在一年内达到无类固醇临床缓解。根据事后分析，几乎所有在一年内达到临床缓解的患者（99%）都不含类固醇。在52周评估结束前，无类固醇临床缓解的患者至少三个月无类固醇。

Among those who achieved clinical remission at 12 weeks, approximately two-thirds (66%) of patients maintained clinical remission through one year of continuous treatment compared to placebo (40%)..

在12周达到临床缓解的患者中，与安慰剂（40%）相比，大约三分之二（66%）的患者通过一年的连续治疗维持临床缓解。。

Rapid improvement of symptoms, such as rectal bleeding and stool frequency, were observed as early as three weeks in patients treated with Omvoh. Notably, the LUCENT trials were the first and only to use the patient-centric, Urgency Numeric Rating Scale (NRS) of 0-10, with zero being no bowel urgency and 10 being worst possible bowel urgency.

Omvoh治疗的患者早在三周就观察到直肠出血和大便次数等症状的快速改善。值得注意的是，LUCENT试验是第一个也是唯一一个使用0-10的以患者为中心的紧急数字评定量表（NRS），零为无肠紧急，10为最差可能的肠紧急。

At baseline, patients had a median Urgency NRS weekly average score of 7. Among patients who had an Urgency NRS weekly average score ≥3 at baseline and responded to induction therapy with Omvoh, a significantly greater proportion of patients (39%) treated with Omvoh achieved a weekly average score of 0 to 1 at one year, compared to placebo (23%)..

在基线时，患者的平均紧急NRS每周平均得分为7。在基线时紧急NRS每周平均评分≥3且对Omvoh诱导治疗有反应的患者中，接受Omvoh治疗的患者比例（39%）在一年内每周平均评分为0-1分安慰剂（23%）。。

'Bowel urgency is one of the most disruptive symptoms for patients with ulcerative colitis,' said Michael Osso, president and chief executive officer, Crohn's & Colitis Foundation. 'Today's approval of Omvoh offers new hope for those who have tried other therapies and still find themselves making accommodations for the uncertainty of bowel urgency-related accidents and other symptoms associated with ulcerative colitis.'.

克罗恩病和结肠炎基金会总裁兼首席执行官Michael Osso说：“肠道急迫是溃疡性结肠炎患者最具破坏性的症状之一。”今天Omvoh的批准为那些尝试过其他疗法的人提供了新的希望，并且仍然发现自己为肠道紧急相关事故和与溃疡性结肠炎相关的其他症状的不确定性做好了准备。

Patients taking Omvoh were less likely to discontinue treatment due to adverse events (1.6% in UC-1 and 1.5% in UC-2) compared to placebo (7.2% in UC-1 and 8.3% in UC-2). The most common adverse reactions (reported in at least 2% of subjects at a higher frequency than placebo) associated with Omvoh treatment were upper respiratory infections, injection site reactions, arthralgia, rash, headache and herpes viral infection.

与安慰剂（UC-1为7.2%，UC-2为8.3%）相比，服用Omvoh的患者由于不良事件（UC-1为1.6%，UC-2为1.5%）而不太可能停止治疗。与Omvoh治疗相关的最常见的不良反应（至少2%的受试者报告的频率高于安慰剂）是上呼吸道感染，注射部位反应，关节痛，皮疹，头痛和疱疹病毒感染。

The labeling for Omvoh contains warnings and precautions related to hypersensitivity reactions, risk of infection, tuberculosis, hepatotoxicity and immunizations. See Important Safety Information below and full Prescribing Information..

Omvoh标签包含与超敏反应，感染风险，结核病，肝毒性和免疫相关的警告和注意事项。请参阅下面的重要安全信息和完整的处方信息。。

'Omvoh addresses key symptoms that matter most to patients and represents our patient-centric approach to treatment innovation,' said Patrik Jonsson, Lilly executive vice president, president of Lilly Immunology and Lilly USA, and chief customer officer. 'Omvoh's approval is a significant moment for Lilly's growing Immunology portfolio, and we are excited to work with the gastroenterology community to set high expectations of care for people living with ulcerative colitis.'.

礼来免疫学和美国礼来公司总裁兼首席客户官帕特里克·琼森（Patrik Jonsson）说：“Omvoh解决了对患者最重要的关键症状，代表了我们以患者为中心的治疗创新方法。”Omvoh的批准是礼来公司不断增长的免疫学产品组合的重要时刻，我们很高兴与胃肠病学界合作，为溃疡性结肠炎患者提供高期望的护理服务。

Omvoh will be available in the United States in the coming weeks. Lilly received approval for Omvoh in Japan and the European Union this year and expects regulatory decisions in additional markets around the world in the coming months.

Omvoh将在未来几周在美国上市。礼来今年在日本和欧盟获得了Omvoh的批准，并预计未来几个月将在全球其他市场做出监管决策。

View the Omvoh brand logo here.

在这里查看Omvoh品牌标志。

About the LUCENT Clinical Trial ProgramOmvoh was studied in two, Phase 3 clinical trials which evaluated the efficacy and safety of Omvoh in adults with moderately to severely active ulcerative colitis (UC) and included patients who had never tried a biologic (biologic-naïve) and harder-to-treat patients who had previously taken a biologic that failed.

关于LUCENT临床试验计划Omvoh在两项3期临床试验中进行了研究，该试验评估了Omvoh在中度至重度活动性溃疡性结肠炎（UC）成人中的疗效和安全性，并包括从未尝试过生物学（生物学天真）和难以治疗先前服用过生物制剂失败的患者。

The induction UC-1 and maintenance UC-2 studies were randomized, double-blind, and placebo-controlled and included those who had inadequate response, loss of response, or failed to tolerate any of the following: corticosteroids, immunomodulators (6-mercaptopurine and azathioprine), biologic therapy (TNF blocker, vedolizumab) or Janus kinase inhibitors (JAKi, tofacitinib).

诱导UC-1和维持UC-2研究是随机，双盲和安慰剂对照的，包括那些反应不足，反应丧失或不能耐受以下任何一种情况的患者：皮质类固醇，免疫调节剂（6-巯基嘌呤和硫唑嘌呤），生物疗法（TNF阻断剂，维多珠单抗）或Janus激酶抑制剂（JAKi，托法替尼）。

Additionally, 41% of patients in UC-1 had failed at least one biologic and 3% had failed a JAKi and 57% were biologic and JAKi-naïve..

此外，UC-1中41%的患者至少一种生物学失败，3%的JAKi失败，57%的生物学和JAKi天真。。

UC-1 was a 12-week induction study (n=1,279) that was followed by UC-2, a 40-week maintenance study (n=581), for a total of 52 weeks of continuous therapy. In UC-1, patients were randomized 3:1 to receive Omvoh (300 mg) IV or placebo IV every 4 weeks for 12 weeks. Patients who achieved clinical response at Week 12 with Omvoh in UC-1 were re-randomized 2:1 to receive Omvoh (200 mg) subcutaneous injection or placebo subcutaneous injection every 4 weeks for another 40 weeks in UC-2..

UC-1是一项为期12周的诱导研究（n=1279），随后是UC-2，一项为期40周的维持研究（n=581），共进行了52周的连续治疗。在UC-1中，患者按3:1随机分组，每4周接受Omvoh（300 mg）IV或安慰剂IV治疗12周。在UC-1中使用Omvoh在第12周达到临床反应的患者以2:1的比例重新随机分配，以在UC-2中每4周接受Omvoh（200 mg）皮下注射或安慰剂皮下注射，持续40周。。

The primary endpoint of UC-1 and UC-2 was clinical remission at Week 12 and Week 52, respectively. The secondary endpoints of UC-1 were clinical response, endoscopic improvement, and histologic-endoscopic mucosal improvement (HEMI) at 12 weeks. The secondary endpoints of UC-2 were endoscopic improvement, maintenance of clinical remission in subjects who achieved clinical remission at 12 weeks, corticosteroid-free clinical remission, HEMI and bowel urgency improvement (defined as patients achieving a weekly average urgency NRS of 0 to 1) at 40 weeks (a total of 52 weeks of treatment)..

UC-1和UC-2的主要终点分别是第12周和第52周的临床缓解。UC-1的次要终点是12周时的临床反应，内镜改善和组织学内镜粘膜改善（HEMI）。UC-2的次要终点是内镜改善，在12周达到临床缓解的受试者中维持临床缓解，无皮质类固醇临床缓解，半和肠紧急改善（定义为达到每周平均紧急NRS为0至1）在40周（总共52周的治疗）。。

Omvoh achieved primary and key secondary endpoints, including sustained clinical remission in pivotal trials.

Omvoh实现了主要和关键的次要终点，包括关键试验中的持续临床缓解。

Of patients treated with Omvoh at 12 weeks in UC-1:

在UC-1中12周用Omvoh治疗的患者：

24% achieved clinical remission compared to 15% of placebo (n=191/795 vs, n=39/267)

24%达到临床缓解，而安慰剂组为15%（n 191/795 vs，n 39/267）

65% achieved a clinical response compared to 43% of placebo (n=514/795 vs, n=116/267)

65%的患者达到了临床反应，而安慰剂组为43%（n 514/795 vs，n 116/267）

34% achieved endoscopic improvement compared to 21% of placebo (n=274/795 vs, n=56/267)

34%的患者获得了内镜改善，而安慰剂组为21%（274/795 vs，56/267）

25% achieved histologic-endoscopic mucosal improvement compared to 14% of placebo (n=200/795 vs, n=38/267)

25%达到组织学内镜粘膜改善，而安慰剂组为14%（n=200/795 vs，n=38/267）

Of patients treated with Omvoh at 40 weeks (a total of 52 weeks of treatment) in UC-2:

在UC-2中40周（总共52周的治疗）用Omvoh治疗的患者：

51% achieved clinical remission compared to 27% of placebo (n=171/337 vs, n=45/169)

51%的患者达到了临床缓解，而安慰剂组为27%（n 171/337 vs，n 45/169）

In a post-hoc analysis, 99% (n=169/171) of patients who achieved clinical remission at one year of treatment were steroid-free for at least the previous 12 weeks.

在事后分析中，99%（n=169/171）在治疗一年达到临床缓解的患者至少在过去12周内无类固醇。

50% achieved corticosteroid-free clinical remission compared to 27% of placebo (n=169/337 vs, n=45/169). Patients in steroid-free remission stopped using corticosteroids for at least the previous 12 weeks prior to the one-year assessment.

50%达到无皮质类固醇的临床缓解，而安慰剂组为27%（n=169/337 vs，n=45/169）。无类固醇缓解的患者至少在一年评估前的12周内停止使用皮质类固醇。

58% achieved endoscopic improvement compared to 30% of placebo (n=195/337 vs, n=50/169)

58%的患者获得了内镜改善，而安慰剂组为30%（n 195/337 vs，n 50/169）

66% achieved maintenance of clinical remission in patients who achieved clinical remission at Week 12 compared to 40% of placebo (n=84/128 vs, n=25/62)

66%的患者在第12周达到临床缓解，而安慰剂组为40%（n 84/128 vs，n 25/62）

43% achieved histologic-endoscopic mucosal improvement compared to 22% of placebo (n=145/337 vs, n=37/169)

与安慰剂组的22%相比，43%的患者获得了组织学内镜粘膜改善（n=145/337 vs，n=37/169）

Bowel urgency was assessed during UC-1 and UC-2 with an Urgency Numeric Rating Scale (NRS) of 0 to 10. Among patients who had an Urgency NRS weekly average score ≥3 at baseline and responded to induction therapy with Omvoh in UC-1, a significantly greater proportion of subjects treated with Omvoh achieved an Urgency NRS weekly average score of 0 to 1 (39% [n=119/307] versus 23% [n=37/160]) at Week 40 in UC-2.

在UC-1和UC-2期间评估肠道紧急程度，紧急数字评定量表（NRS）为0至10。在基线时紧急NRS每周平均评分≥3且在UC-1中对Omvoh诱导治疗有反应的患者中，用Omvoh治疗的受试者比例显着更高，达到紧急NRS每周平均评分0-1（39%[n=119/307]与23%[n=37/160]）在UC-2的第40周。

Urgency NRS weekly average scores of 0 to 1 were also observed in a greater proportion of subjects treated with Omvoh compared to placebo at 12 weeks in UC-1..

在UC-1中，与安慰剂相比，在12周时用Omvoh治疗的受试者中也观察到紧急NRS每周平均评分为0-1。。

Decreases in rectal bleeding and stool frequency subscores were observed as early as three weeks in subjects treated with Omvoh compared to placebo.

与安慰剂相比，早在用Omvoh治疗的受试者中观察到直肠出血和大便次数分数的减少。

Adverse reactions were reported in at least 2% of subjects at a higher frequency than placebo during induction and maintenance trials:

在诱导和维持试验期间，至少2%的受试者报告的不良反应频率高于安慰剂：

Induction

归纳

8% of patients taking Omvoh (n=72/958) experienced upper respiratory infections versus 6% on placebo (n=20/321) in UC-1

8%服用Omvoh的患者（72/958）出现上呼吸道感染，而安慰剂组（20/321）出现上呼吸道感染的比例为6%

2% of patients taking Omvoh (n=20/958) experienced arthralgia versus 1% on placebo (n=4/321) in UC-2

2%服用Omvoh的患者（n 20/958）出现关节痛，而安慰剂组（n 4/321）出现关节痛

Maintenance

维护

14% of patients taking Omvoh (n=53/389) experienced upper respiratory infections versus 12% on placebo (n=23/192)

14%服用Omvoh的患者（53/389）出现上呼吸道感染，而安慰剂组为12%（23/192）

9% of patients taking Omvoh (n=34/389) experienced injection-site reactions versus 4% on placebo (n=8/192)

9%服用Omvoh的患者（34/389）出现注射部位反应，而安慰剂组为4%（8/192）

7% of patients taking Omvoh (n=26/389) experienced arthralgia versus 4% on placebo (n=8/192)

7%服用Omvoh的患者（26/389）出现关节痛，4%服用安慰剂（8/192）

4% of patients taking Omvoh (n=16/389) experienced rash versus 1% on placebo (n=2/192)

4%服用Omvoh的患者（16/389）出现皮疹，而安慰剂组为1%（2/192）

4% of patients taking Omvoh (n=16/389) experienced headache versus 1% on placebo (n=2/192)

服用Omvoh的患者中有4%（16/389）出现头痛，而服用安慰剂的患者中有1%（2/192）出现头痛

2% of patients taking Omvoh (n=9/389) experienced herpes viral infection versus 1% on placebo (n=1/192)

2%服用Omvoh的患者（9/389）经历了疱疹病毒感染，而安慰剂组为1%（1/192）

Lilly is committed to helping people access the medicines they are prescribed and will work with insurers, health systems and providers to help enable patient access to Omvoh. Lilly will offer an Omvoh savings card for people who qualify. Patients or healthcare professionals with questions about Omvoh can visit www.Omvoh.com or call The Lilly Answers Center at 1-800-LillyRx (1-800-545-5979)..

礼来公司致力于帮助人们获得他们处方的药物，并将与保险公司，卫生系统和供应商合作，帮助患者获得Omvoh。礼来公司将为符合条件的人士提供Omvoh储蓄卡。有关Omvoh问题的患者或医疗保健专业人员可以访问www.Omvoh.com或致电1-800-LillyRx（1-800-545-5979）的Lilly Anvers Center。。

Indications and Usage for Omvoh™ (mirikizumab-mrkz) (in the United States)

Omvoh的适应症和用法™ （mirikizumab mrkz）（在美国）

Omvoh™ is indicated for the treatment of moderately to severely active ulcerative colitis in adults.

奥姆沃™ 适用于治疗成人中度至重度活动性溃疡性结肠炎。

Important Safety Information for Omvoh (mirikizumab-mrkz)

Omvoh（mirikizumab mrkz）的重要安全信息

CONTRAINDICATIONS - Omvoh is contraindicated in patients with a history of serious hypersensitivity reaction to mirikizumab-mrkz or any of the excipients.

禁忌症-对米立单抗mrkz或任何赋形剂有严重超敏反应史的患者禁用Omvoh。

WARNINGS AND PRECAUTIONS

警告和注意事项

Hypersensitivity Reactions

超敏反应

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..

Omvoh给药已经报道了严重的超敏反应，包括静脉输注期间的过敏反应。在诱导期间报告了输注相关的超敏反应，包括粘膜皮肤红斑和瘙痒。如果发生严重的超敏反应，立即停用Omvoh并开始适当的治疗。。

Infections

感染

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.

Omvoh可能会增加感染的风险。在感染消退或得到充分治疗之前，不要在患有临床重要活动性感染的患者中开始使用Omvoh治疗。对于慢性感染或复发感染史的患者，在开具Omvoh之前考虑风险和益处。

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..

如果出现临床上重要的急性或慢性感染的体征或症状，请指导患者寻求医疗建议。如果发生严重感染或感染对标准治疗无效，请密切监测患者，在感染消退前不要给予Omvoh。。

Tuberculosis

结核

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.

在开始用Omvoh治疗之前评估患者的结核病（TB）感染。不要给活动性结核感染患者服用Omvoh。在施用Omvoh之前开始治疗潜伏性TB。对于有潜伏或活动性结核病史的患者，在开始Omvoh之前考虑抗结核治疗，其中无法确定适当的治疗方案。

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..

在Omvoh治疗期间和之后监测患者活动性结核病的体征和症状。在临床试验中，如果受试者有活动性结核病证据，活动性结核病史或在筛查时被诊断为潜伏性结核病，则排除受试者。。

Hepatotoxicity

肝毒性

Drug-induced liver injury in conjunction with pruritus was reported in a clinical trial patient 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.

临床试验患者在推荐的诱导方案之后报告了与瘙痒相关的药物诱导的肝损伤。Omvoh已停产。肝测试异常最终返回基线。在基线和至少24周的治疗中评估肝酶和胆红素。

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.

此后根据常规患者管理进行监测。考虑有肝硬化证据的患者的其他治疗方案。建议及时调查肝酶升高的原因，以确定潜在的药物性肝损伤病例。如果怀疑药物性肝损伤，中断治疗，直至排除此诊断。

Instruct patients to seek immediate medical attention if they experience symptoms suggestive of hepatic dysfunction..

如果患者出现提示肝功能不全的症状，请指导患者立即就医。。

Immunizations

疫苗接种

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.

避免在接受Omvoh治疗的患者中使用活疫苗。与免疫系统相互作用的药物可能会增加接种活疫苗后感染的风险。在开始治疗之前，根据目前的免疫接种指南完成所有适合年龄的疫苗接种。

No data are available on the response to live or non-live vaccines in patients treated with Omvoh..

没有关于Omvoh治疗患者对活疫苗或非活疫苗反应的数据。。

ADVERSE REACTIONS

不良反应

Most common adverse reactions (≥2%) associated with Omvoh treatment are upper respiratory tract infections and arthralgia during induction, and upper respiratory tract infections, injection site reactions, arthralgia, rash, headache, and herpes viral infection during maintenance.

与Omvoh治疗相关的最常见不良反应（≥2%）是诱导期间的上呼吸道感染和关节痛，以及维持期间的上呼吸道感染，注射部位反应，关节痛，皮疹，头痛和疱疹病毒感染。

MR HCP ISI UC APP

HCP先生ISI UC应用程序

Please click for Prescribing Information and Medication Guide for Omvoh. Please click for Instructions for Use included with the device.

请点击Omvoh的处方信息和药物指南。请单击设备随附的使用说明。

About Omvoh™Omvoh (mirikizumab-mrkz) is an interleukin-23p19 antagonist indicated for the treatment of moderately to severely active ulcerative colitis 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 UC.

关于Omvoh™Omvoh（mirikizumab mrkz）是一种白细胞介素-23p19拮抗剂，用于治疗成人中度至重度活动性溃疡性结肠炎。Omvoh选择性靶向IL-23的p19亚基并抑制IL-23途径。由于IL-23途径的过度激活引起的炎症在UC的发病机理中起关键作用。

Treatment with Omvoh starts with 300-mg IV infusions, once a week every four weeks for a total of three infusions, and transitions to two, 100-mg subcutaneous self-injections every four weeks during maintenance treatment..

Omvoh的治疗始于300 mg静脉输注，每周四次，共三次输注，并在维持治疗期间每四周过渡到两次100 mg皮下自我注射。。

About LillyLilly unites caring with discovery to create medicines that make life better for people around the world. We've been pioneering life-changing discoveries for nearly 150 years, and today our medicines help more than 51 million 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.

关于礼来公司联合关怀发现，创造药物，使世界各地的人们生活更好。近150年来，我们一直在开拓改变生活的发现，今天我们的药物帮助全球超过5100万人。利用生物技术，化学和遗传医学的力量，我们的科学家正在紧急推进新发现，以解决世界上一些最重大的健康挑战，重新定义糖尿病护理，治疗肥胖症并减少其最具破坏性的长期影响，推进与阿尔茨海默氏症的斗争疾病，为一些最令人衰弱的免疫系统疾病提供解决方案，并将最难治疗的癌症转变为可控制的疾病。

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 Lilly.com and Lilly.com/news or follow us on Facebook, Instagram, Twitter and LinkedIn.

随着迈向更健康世界的每一步，我们都受到一件事的激励：为数百万人创造更好的生活。其中包括提供反映我们世界多样性的创新临床试验，并努力确保我们的药物易于获得且价格合理。要了解更多信息，请访问Lilly.com和Lilly.com/news，或在Facebook，Instagram，Twitter和LinkedIn上关注我们。

P-LLY.

P-LLY。

*Disclosure: Dr. Sands is a paid consultant for Lilly. He has not been compensated for any media work.

*披露：Sands博士是Lilly的付费顾问。他没有得到任何媒体工作的补偿。

Omvoh™ and its delivery device base are trademarks owned by Eli Lilly and Company.

奥姆沃™ 及其交付设备基础是礼来公司（Eli Lilly and Company）拥有的商标。

Cautionary Statement Regarding Forward-Looking StatementsThis press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about Omvoh as a treatment for people with moderately to severely active ulcerative colitis and reflects Lilly's current beliefs and expectations.

关于前瞻性声明的警示声明本新闻稿包含关于Omvoh治疗中度至重度活动性溃疡性结肠炎患者的前瞻性声明（如1995年“私人证券诉讼改革法”中所定义），并反映了礼来公司目前的信念和期望。

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, or that Omvoh will receive additional regulatory approvals, or be commercially successful.

然而，与任何药品一样，药物研究，开发和商业化过程中存在重大风险和不确定性。除其他外，不能保证计划或正在进行的研究将按计划完成，未来的研究结果将与迄今为止的研究结果一致，或Omvoh将获得额外的监管批准，或取得商业成功。

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..

有关可能导致实际结果与礼来公司预期不同的这些风险和其他风险及不确定性的进一步讨论，请参阅礼来公司的Form 10-K和Form 10-Q与美国证券交易所委员会的申请。除法律要求外，礼来公司不承担更新前瞻性声明的责任，以反映本版本发布之日以后的事件。。

PP-MR-US-0132 10/2023 © Lilly USA, LLC 2023. All rights reserved.

PP-MR-US-0132 10/2023©Lilly USA，LLC 2023。版权所有。

Refer to:

参考：

Rachel Sorvig; [email protected]; +1-317-607-7507 (Lilly media)

雷切尔·索维格；[电子邮件保护]+1-317-607-7507（礼来媒体）

Joe Fletcher; [email protected]; +1-317-296-2884 (Lilly investors)

乔·弗莱彻；[电子邮件保护]+1-317-296-2884（礼来投资者）

SOURCE Eli Lilly and Company

来源礼来公司