Omvoh Now Approved

The first approved IL-23p19 inhibitor for moderate to severe ulcerative colitis patients1,2

Omvoh Now Approved

The first approved IL-23p19 inhibitor for moderate to severe ulcerative colitis patients1,2

Omvoh Now Approved

Omvoh the first approved IL-23p19 inhibitor for moderate to severe ulcerative colitis patients1,2

Omvoh Now Approved

Omvoh the first approved IL-23p19 inhibitor for moderate to severe ulcerative colitis patients1,2

Omvoh Now Approved

Omvoh the first approved IL-23p19 inhibitor for moderate to severe ulcerative colitis patients1,2

Omvoh Now Approved

Omvoh the first approved IL-23p19 inhibitor for moderate to severe ulcerative colitis patients1,2

Make the Urgent Change with Omvoh

Omvoh helped patients achieve sustained clinical remission and reduced bowel urgency severity1

Sustained Clinical Remission

50% of patients achieved clinical remission at week 52 with Omvoh1

Reduces the Disruptive Impact of Bowel Urgency

43% of patients taking Omvoh achieved bowel urgency remission at week 521,3,4

Well Tolerated Safety Profile from Two Phase 3 Trials

Well tolerated with similar adverse events and discontinuation rates comparable to placebo through 52 weeks1

Latest Updates

From latest articles to infographics, we’ve got you covered. Explore what’s new and stay in the loop!

Know more about the bowel urgency efficacy data

Learn more about how Omvoh can help your UC patients with their most burdensome symptom

Review the efficacy data of the LUCENT-2 trial

Why Omvoh should be the prefered choice for patients with moderately to severely active UC

References
  • Omvoh USPI October 2023.
  • Mirikizumab demonstrates superiority over placebo in phase 3 maintenance study in ulcerative colitis, supporting regulatory submissions in 2022. Eli Lilly and Company. December 14, 2021. Accessed June, 2024.
    https://investor.lilly.com/news-releases/news-release-details/mirikizumab-demonstratessuperiority- over-placebo-phase-3
  • Carpio D, Lopez-Sanromon A, Calvet X, et al. Perception of disease burden and treatment satisfaction in patients with ulcerative colitis from outpatient clinics in Spain: UC-LIFE survey. Eur J Gastroenterol Hepatol. 2016;28(9):1056-1064. doi:10.1097/MEG.0000000000000658
  • D'Hagens G, Dubinsky M, Kobayashi T, et al. Mirikizumab as induction and maintenance therapy for ulcerative colitis. N Engl J Med. 2023;388(26):2444-2455. doi:10.1056/NEJMoa2207940.

“I plan, map out where bathrooms are, and always carry an emergency bag of supplies. But I want another option for my ulcerative colitis symptoms so I’m not always wondering what if bowel urgency strikes and I can’t make it?”*

Mia

*Hypothetical patient

“I plan, map out where bathrooms are, and always carry an emergency bag of supplies. But I want another option for my ulcerative colitis symptoms so I’m not always wondering what if bowel urgency strikes and I can’t make it?”*

Mia

*Hypothetical patient

Consider Omvoh for your patients with UC when you’ve decided it’s time for a different treatment1

Mia has moderately to severely active UC and is still experiencing ulcerative colitis symptoms

She continues to experience bowel urgency and other symptoms, like rectal bleeding or frequent stools2
Bowel urgency is her most bothersome symptom, causing worry that she may not make it to the toilet on time every time3,4
You’ve determined Mia is ready for a biologic
References
  • Omvoh Summary of Product Characteristics, Eli Lilly, UAE, 2024.
  • Rubin D, Panaccione R, Potts Bleakman A, et al. P028 Communicating needs and features of IBD experiences (CONFIDE) survey: patient and healthcare professional perspectives on experience of ulcerative colitis symptoms. Am J Gastroenterol. 2021;116:S7. doi:10.14309/01. ajg.0000798712.28363.8b
  • Schreiber S, Panés J, Louis E, Holley D, Buch M, Paridaens K. Perception gaps between patients with ulcerative colitis and healthcare professionals: an online survey. BMC Gastroenterol.2012;12:108. doi: 10.1186/1471-230X-12-108
  • Dibley L, Norton C. Experiences of fecal incontinence in people with inflammatory bowel disease: self-reported experiences among a community sample. Inflamm Bowel Dis. 2013;19(7):1450-1462. doi:10.1097/ MIB.0b013e318281327f

Omvoh-A first-in-class IL-23p19 antagonist for the treatment of moderately to severely UC1-3

Omvoh selectively targets the p19 subunit of IL-23 and inhibits the IL-23 pathway1

Inflamation due to over activation of the IL-23 pathway plays a critical role in the pathogenesis of UC1

Omvoh spares the IL-21 pathway, preserving the protective role of IL-12 in immune responses1,4

References
  • Omvoh USPI October 2023.
  • Mirikizumab demonstrates superiority over placebo in phase 3 maintenance study in ulcerative colitis, supporting regulatory submissions in 2022. Ell Lilly and C December 14, 2021. Accessed June, 2024. https://investor.lilly.com/news-releases/news-release-details/mirikizumab-demonstratessuperiority- over-placebo-ph
  • Teng MW, Bowman EP, McElwee JJ, et al. IL-12 and IL-23 cytokines: from discovery to targeted therapies for immune-mediated inflammatory diseases. Nat Med. 2015;21(7):719-729. doi:10.1038.nm.3985
  • Hamza T, Barnett JB, LI B. Interleukin 12 a key immunoregulatory cytokine in infection applications. Int J Mol Sci. 2010;11(3):789-806. doi:10.3390/ijms11030789

Evaluating the efficacy and safety of Omvoh in adult patients with moderately to severely active UC1

Omvoh was evaluated in two Phase 3, randomized, double-blind, placebo-controlled clinical trials1,3

At baseline, all patients had inadequate response, loss of response, or intolerance to at least one corticosteroid, immunomodulator, biologic treatment, or tofacitinib for UC1

aLUCENT-1 was a 12-week blinded induction study with patients randomized to Omvoh (300 mg) IV or placebo IV every 4 weeks.1
bIn LUCENT-2, patients who achieved clinical response with Omvoh in LUCENT-1 were re-randomized to Omvoh (200 mg) SC or placebo SC every 4 weeks for an additional 40 weeks.1
cLoss of response led to a reinitiating of open-label Omvoh (300 mg) IV Q4W for 3 doses. Patients who did not experience clinical benefit discontinued Omvoh.1,3
IV=intravenous; Q4W=every 4 weeks; SC=subcutaneous; UC=ulcerative colitis.

The Omvoh trials included patients who had been treated with prior biologic and those who were bio-naive1

41% of patients in LUCENT-1 and 35% of patients in LUCENT-2 had failed at least one prior biologic1-4

Bio-naive=biologic-naive; IV=intravenous; SC=subcutaneous; TNF=tumor necrosis factor.

PRIOR THERAPIES

Of the 479 patients in LUCENT-1 who failed a prior biologic or tofacitinib4:
  • 88.1% had prior anti-TNF failure
  • 45.5% had prior vedolizumab failure
  • 8.3% had prior tofacitinib failure

TNF=tumor necrosis factor.

Of the 192 patients in LUCENT-2 who failed a prior biologic or tofacitinib3:
  • 88.5% had prior anti-TNF failure
  • 36.4% had prior vedolizumab failure
  • 8.3% had prior tofacitinib failure
References
  • D’Haens G, Dubinsky M, Kobayashi T. et al. Mirikizumab as induction and maintenance therapy for ulcerative colitis. N Engl J Med 2023;388(26):2444-2455. doi:10.1056/NEJMoa2207940.

Evaluating the efficacy and safety of Omvoh in adult patients with moderately to severely active UC

Omvoh was evaluated in two Phase 3, randomized, double-blind, placebo-controlled clinical trials

At baseline, all patients had inadequate response, loss of response, or intolerance to at least one corticosteroid, immunomodulator, biologic treatment, or tofacitinib for UC

aLUCENT-1 was a 12-week blinded induction study with patients randomized to Omvoh (300 mg) IV or placebo IV every 4 weeks.
bIn LUCENT-2, patients who achieved clinical response with Omvoh in LUCENT-1 were re-randomized to Omvoh (200 mg) SC or placebo SC every 4 weeks for an additional 40 weeks.
cLoss of response led to a reinitiating of open-label Omvoh (300 mg) IV Q4W for 3 doses. Patients who did not experience clinical benefit discontinued Omvoh.1,3
IV=intravenous; Q4W=every 4 weeks; SC=subcutaneous; UC=ulcerative colitis.

X

Nearly 2 in 3 patients taking Omvoh achieved clinical response at Week 121

64% of patients taking Omvoh achieved clinical response after 12 weeks of induction dosing

aClinical response at Week 12 was defined as ≥2-point and ≥30% decrease in the MMS from baseline; RB=0 or 1, or a ≥1-point decrease from baseline.1
ES=endoscopic subscore; IV=intravenous; MMS=Modified Mayo Score; Q4W=every 4 weeks; RB=rectal bleeding subscore; SF=stool frequency subscore.

Nearly 1 in 4 patients taking Omvoh achieved clinical remission at Week 121

24% of patients taking Omvoh achieved clinical remission after 12 weeks of induction dosing1

bClinical remission at Week 12 was defined as SF=0, or SF=1 with a ≥1-point decrease from baseline; RB=0; ES=0 or 1 (excluding friability).1ES=endoscopic subscore; IV=intravenous; MMS=Modified Mayo Score; Q4W=every 4 weeks; RB=rectal bleeding subscore; SF=stool frequency subscore.

AMONG PATIENTS WHO ACHIEVED CLINICAL RESPONSE WITH OMVOH IN LUCENT-11

Nearly 2 in 3 patients taking Omvoh achieved clinical response at Week 121

* The data presented are from a post hoc analysis and were not type I error controlled. Therefore treatment differences between Omvoh and placebo cannot be regarded as statistically significant.2
aClinical remission was defined as SF=0, or SF=1 with a ≥1-point decrease from baseline; RB=0; ES=0 or 1 (excluding friability).1
bBio-failed includes biologic-failed and tofacitinib-failed patients. An additional 1 patient on placebo and 8 patients on Omvoh were previously exposed to but did not fail a biologic or JAKi.These patients were excluded from the bio-naive/bio-failed subgroup analysis.1
Bio-failed=biologic-failed; bio-naive=biologic-naive; ES=endoscopic subscore; Q4W=every 4 weeks; RB=rectal bleeding subscore; SC=subcutaneous; SF=stool frequency subscore.

AMONG PATIENTS WHO ACHIEVED CLINICAL RESPONSE WITH OMVOH IN LUCENT-11

Omvoh demonstrated durable clinical remission at Week 521

64% of patients maintained clinical remission through 1 year of continuous treatment with Omvoh1

aClinical remission was defined as SF=0, or SF=1 with a ≥1-point decrease from baseline; RB=0; ES=0 or 1 (excluding friability).1
bBio-failed includes biologic-failed and tofacitinib-failed patients. An additional 1 patient on placebo and 8 patients on Omvoh were previously exposed to but did not fail a biologic or JAKi.These patients were excluded from the bio-naive/bio-failed subgroup analysis.1
Bio-failed=biologic-failed; bio-naive=biologic-naive; ES=endoscopic subscore; Q4W=every 4 weeks; RB=rectal bleeding subscore; SC=subcutaneous; SF=stool frequency subscore.

AMONG PATIENTS WHO ACHIEVED CLINICAL RESPONSE WITH OMVOH IN LUCENT-11

45% of patients were in corticosteroid-free remission at Week 521

aCorticosteroid-free clinical remission without surgery was defined as clinical remission at Week 40 in LUCENT-2; symptomatic remission at Week 28; no corticosteroid use for ≥12 weeks prior to Week 40. Denominator includes all patients irrespective of baseline corticosteroid use status.1
bBio-failed includes biologic-failed and tofacitinib-failed patients. An additional 1 patient on placebo and 8 patients on Omvoh were previously exposed to but did not fail a biologic or JAKi.
These patients were excluded from the bio-naive/bio-failed subgroup analysis.1Week 52/1 year is defined as the 12-week induction study (LUCENT-1) plus the 40-week maintenance study (LUCENT-2) for 52 weeks of continuous treatment
.Bio-failed=biologic-failed; bio-naive=biologic-naive; Q4W=every 4 weeks; SC=subcutaneous.

References
  • Omvoh USPI October 2023.
  • D’Haens G, Dubinsky M, Kobayashi T, et al. Mirikizumab as induction and maintenance therapy for ulcerative colitis. N Engl J Med 2023;388(26):2444-2455. doi:10.1056/NEJMoa2207940.

AMONG PATIENTS WHO ACHIEVED CLINICAL RESPONSE WITH OMVOH IN LUCENT-11

Nearly 60% of patients taking Omvoh achieved endoscopic remission at Week 521

aEndoscopic remission was defined as ES=0 or 1 (excluding friability).1
bBio-failed includes biologic-failed and tofacitinib-failed patients. An additional 1 patient on placebo and 8 patients on Omvoh were previously exposed to but did not fail a biologic or JAKi.
These patients were excluded from the bio-naive/bio-failed subgroup analysis.1
Bio-failed=biologic-failed; bio-naive=biologic-naive; ES=endoscopic subscore; Q4W=every 4 weeks; SC=subcutaneous.

AMONG PATIENTS WHO ACHIEVED CLINICAL RESPONSE WITH OMVOH IN LUCENT-11

Omvoh demonstrated histologic-endoscopic mucosal remission (HEMR) at Week 521

aClinical remission was defined as SF=0, or SF=1 with a ≥1-point decrease from baseline; RB=0; ES=0 or 1 (excluding friability).1
bBio-failed includes biologic-failed and tofacitinib-failed patients. An additional 1 patient on placebo and 8 patients on Omvoh were previously exposed to but did not fail a biologic or JAKi.
These patients were excluded from the bio-naive/bio-failed subgroup analysis.1
Bio-failed=biologic-failed; bio-naive=biologic-naive; ES=endoscopic subscore; Q4W=every 4 weeks; RB=rectal bleeding subscore; SC=subcutaneous; SF=stool frequency subscore.

References
  • Omvoh USPI October 2023.
  • D’Haens G, Dubinsky M, Kobayashi T, et al. Mirikizumab as induction and maintenance therapy for ulcerative colitis. N Engl J Med 2023;388(26):2444-2455. doi:10.1056/NEJMoa2207940.

UC guidelines highlight addressing bowel urgency as an important treatment goal1

47% of patients (n=72/153) on advanced therapy reported wearing a diaper, pad,or other protection at least once a weekdue to worry or anticipation of a bowel urgency accident.2

According to the European Crohn’s and Colitis Organisation (ECCO), bowel urgency is a symptom of active disease and should be addressed in medical examinations of patients with UC.3

Despite the ECCO recommendations, the definition of clinical remission in UC clinical trials does not include bowel urgency.1,4

Omvoh is one of the first UC treatments to assess bowel urgency as a key secondary endpoint in clinical trials.5,6

Omvoh provided improvement of UC symptoms through Week 125,6

Bowel urgency was assessed by patients using the 11-point UNRS, which measured the severity of urgency to have a bowel movement ranging from 0 (no urgency) to 10 (worst possible urgency).4

aSymptomatic remission was defined as SF=0, or SF=1 with a ≥1-point decrease from baseline; RB=0.4,5
bSymptomatic remission was measured as a gated secondary endpoint at Weeks 4 and 12, therefore statistical significance is shown for these time points only.5
IV=intravenous; LSM=least squares mean; Q4W=every 4 weeks; RB=rectal bleeding subscore; SF=stool frequency subscore; UC=ulcerative colitis; UNRS=Urgency Numeric Rating Scale.

AMONG PATIENTS WHO ACHIEVED CLINICAL RESPONSE WITH OMVOH IN LUCENT-15

Omvoh reduced the disruptive impact of bowel urgency5,7

43% of patients taking Omvoh achieved bowel urgency remission at Week 525

Bowel urgency was assessed by patients using the 11-point UNRS, which measured the severity of urgency to have a bowel movement ranging from 0 (no urgency) to 10 (worst possible urgency).5*

*Patients included in this analysis had a UNRS score of ≥3 at baseline in LUCENT-1.5
aBowel urgency remission: Patients rating bowel urgency severity as 0 or 1 on UNRS (0-10).4,5
Q4W=every 4 weeks; SC=subcutaneous; UNRS=Urgency Numeric Rating Scale.

AMONG PATIENTS WHO ACHIEVED CLINICAL RESPONSE WITH OMVOH IN LUCENT-15

Clinically meaningful improvement in bowel urgency with Omvoh at Week 528

65% of patients achieved clinically meaningful improvement in bowel urgency severity with Omvoh8*

Bowel urgency was assessed by patients using the 11-point UNRS, which measured the severity of urgency to have a bowel movement ranging from 0 (no urgency) to 10 (worst possible urgency).5*

*Clinically meaningful improvement in bowel uregency severity was defined as ≥3-point decrease from baseline in UNRS among patients with UNRS ≥3 at baseline.8
The data presented are from a post hoc analysis and were not type error controlled. Therefore treatment differences between Omvoh and placebo cannot be regarded as statistically significant. Q4W=every 4 weeks; SC=subcutaneous; UC=ulcerative colitis; UNRS=Urgency Numeric Rating Scale.

References
  • Rubin DT, Ananthakrishnan AN, Siegel CA, Sauer BG, Long MD. ACG clinical guideline: ulcerative colitis in adults. Am J Gastroenterol. 2019;114:384-413. doi:10.14309/ajg.0000000000000152.
  • Schreiber S, Travis S, Potts Bleakman A, et al. Communicating needs and features of IBD experiences (CONFIDE) survey: burden and impact of bowel urgency on patients with moderate to severe ulcerative colitis. Gastroenterology. 2022;162:S79-S112. doi:10.1093/ibd/izac015.127
  • Magro F, Gionchetti P, Eliakim R, et al. Third European evidence-based consensus on diagnosis and management of ulcerative colitis. Part 1: Definitions, diagnosis, extra-intestinal manifestations, pregnancy, cancer surveillance, surgery, and ileo-anal pouch disorders. J Crohns Colitis. 2017;11(6):649- 670. doi:10.1093/ecco-jcc/jjx008
  • Dubinsky MC, Irving PM, Panaccione R, et al. Incorporating patient experience into drug development for ulcerative colitis: development of the Urgency Numeric Rating Scale, a patient-reported outcome measure to assess bowel urgency in adults. J Patient Rep Outcomes. 2022;6(1):31. doi:10.1186/s41687-022-00439-w
  • Omvoh USPI October 2023.
  • D’Haens G, Dubinsky M, Kobayashi T, et al. Mirikizumab as induction and maintenance therapy for ulcerative colitis. N Engl J Med 2023;388(26):2444-2455. doi:10.1056/NEJMoa2207940.patient-reported outcome measure to assess bowel urgency in adults. J Patient Rep Outcomes. 2022;6(1):31. doi:10.1186/s41687-022-00439-w
  • Carpio D, Lopez-Sanrom􀀀n A, Calvet X, et al. Perception of disease burden and treatment satisfaction in patients with ulcerative colitis from outpatient clinics in Spain: UC-LIFE survey. Eur J Gastroenterol Hepatol.2016;28(9):1056-1064. doi:10.1097/MEG.0000000000000658
  • Dubinsky MC, Clemow DB, Hunter Gibble T, et al. Clinical effect of mirikizumab treatment on bowel urgency in patients with moderately

Evaluating the efficacy and safety of Omvoh in adult patients with moderately to severely active UC

Omvoh was evaluated in two Phase 3, randomized, double-blind, placebo-controlled clinical trials

At baseline, all patients had inadequate response, loss of response, or intolerance to at least one corticosteroid, immunomodulator, biologic treatment, or tofacitinib for UC

aLUCENT-1 was a 12-week blinded induction study with patients randomized to Omvoh (300 mg) IV or placebo IV every 4 weeks.
bIn LUCENT-2, patients who achieved clinical response with Omvoh in LUCENT-1 were re-randomized to Omvoh (200 mg) SC or placebo SC every 4 weeks for an additional 40 weeks.
cLoss of response led to a reinitiating of open-label Omvoh (300 mg) IV Q4W for 3 doses. Patients who did not experience clinical benefit discontinued Omvoh.1,3
IV=intravenous; Q4W=every 4 weeks; SC=subcutaneous; UC=ulcerative colitis.

X

The safety of Omvoh was evaluated in two randomized, double-blind, placebo-controlled Phase 3 trials1

aOccurring in ≥3% of patients in any treatment group during induction or maintenance; listed by decreasing frequency in the Omvoh arm during maintenance.1
bThe most frequent events were injection site pain, injection site reaction, and injection site erythema. These symptoms were usually reported as non-serious, mild, and transient in nature.2
IV=intravenous; SC=subcutaneous.

The majority of injection-site reactions were mild to moderate and did not lead to discontinuation of Omvoh2, 3

In the maintenance study (LUCENT-2), injection-site reactions were reported by 9% of patients taking Omvoh compared to 4% of patients taking placebo.1,2

The most frequently reported reactions were:

    • Injection-site pain1
    • Injection-site reaction1
    • Injection-site erythema1

    1 patient (0.3%) taking Omvoh discontinued treatment due to injection-site hypersensitivity.2,3

    References
    • Omvoh USPI October 2023.
    • D’Haens G, Dubinsky M, Kobayashi T, et al. Mirikizumab as induction and maintenance therapy for ulcerative colitis. N Engl J Med. 2023;388(26):2444-2455. doi:10.1056/NEJMoa2207940
    • Data on File. REF-65619. Eli Lilly and Company.

    Omvoh had numerically lower frequencies of serious adverse events and discontinuations vs placebo1

    aIn the induction trial, 1 case of herpes zoster infection was reported in the placebo group, and 1 case of esophageal candidiasis, 2 of cytomegalovirus colitis, 1 of herpes zoster infection, and 1 of intestinal tuberculosis were reported in the Omvoh group; cytomegalovirus colitis was severe in 1 patient. In the maintenance trial, 1 case of oral candidiasis and 4 cases of herpes zoster infection were reported in the Omvoh group. Herpes zoster infection was severe in 1 patient. Other opportunistic infections during both the induction and maintenance trials were mild to moderate, and none resulted in discontinuation of Omvoh. In the open-label extension trial, 3 cases of herpes zoster infection, 1 case of esophageal candidiasis, and 1 case of oral candidiasis were reported in patients taking Omvoh.1
    bNo instances of major adverse cardiovascular events (MACE) during induction; 1 instance of MACE (ischemic stroke) in the placebo group during maintenance; 1 instance of MACE reported during LUCENT-3, determined by the investigator as not related to Omvoh.1,2
    cIn the Omvoh group during the induction trial, both cancers were colon adenocarcinoma. During the maintenance trial, nonmelanoma skin cancer (basal cell carcinoma) occurred in 1 patient in the placebo group and gastric cancer in 1 patient in the Omvoh group.1
    dNo serious hypersensitivity or anaphylactic reactions occurred during the induction trial. One case of anaphylaxis occurred in the placebo group during the maintenance trial. In the open-label extension trial, 1 case of allergic sinusitis, 1 case of eczema, 1 case of injection site hypersensitivity, and 1 case of injection site urticaria were reported in patients taking Omvoh.1

    AE=adverse event; IV=intravenous; SC=subcutaneous.

    The safety profile of Omvoh at 2 years is consistent with earlier data1, 2

    aIn the induction trial, 1 case of herpes zoster infection was reported in the placebo group, and 1 case of esophageal candidiasis, 2 of cytomegalovirus colitis, 1 of herpes zoster infection, and 1 of intestinal tuberculosis were reported in the Omvoh group; cytomegalovirus colitis was severe in 1 patient. In the maintenance trial, 1 case of oral candidiasis and 4 cases of herpes zoster infection were reported in the Omvoh group. Herpes zoster infection was severe in 1 patient. Other opportunistic infections during both the induction and maintenance trials were mild to moderate, and none resulted in discontinuation of Omvoh. In the open-label extension trial, 3 cases of herpes zoster infection, 1 case of esophageal candidiasis, and 1 case of oral candidiasis were reported in patients taking Omvoh.1
    bNo instances of major adverse cardiovascular events (MACE) during induction; 1 instance of MACE (ischemic stroke) in the placebo group during maintenance; 1 instance of MACE reported during LUCENT-3, determined by the investigator as not related to Omvoh.1,2
    cIn the Omvoh group during the induction trial, both cancers were colon adenocarcinoma. During the maintenance trial, nonmelanoma skin cancer (basal cell carcinoma) occurred in 1 patient in the placebo group and gastric cancer in 1 patient in the Omvoh group.1
    dNo serious hypersensitivity or anaphylactic reactions occurred during the induction trial. One case of anaphylaxis occurred in the placebo group during the maintenance trial. In the open-label extension trial, 1 case of allergic sinusitis, 1 case of eczema, 1 case of injection site hypersensitivity, and 1 case of injection site urticaria were reported in patients taking Omvoh.1

    References
    • D’Haens G, Dubinsky M, Kobayashi T, et al. Mirikizumab as induction and maintenance therapy for ulcerative colitis. N Engl J Med. 20 2023;388(26):2444-2455. doi:10.1056/NEJMoa2207940.
    • Sands BE, D’Haens G, Clemow DB, et al. Two-year efficacy and safety of mirikizumab following 104 weeks of continuous treatment: results from the LUCENT-3 open-label extension study. Inflammatory Bowel Diseases, 2024, XX, 1-14 https://doi.org/10.1093/ibd/izae024.

    Getting started with Omvoh

    Omvoh dosing begins with 3 induction doses via infusion every 4 weeks and transitions to self-injections for maintenance1

    START WITH INFUSIONS

    300 mg (IV)a at Weeks 0, 4, and 8b

    • IV infusions with Omvoh are administered every 4 weeks for 3 doses before transitioning to maintenance dosing at Week 12 for patients who have achieved adequate therapeutic response1
    START WITH INFUSIONS

    200 mg (SC) via 2 consecutive injections every 4 weeks starting at Week 12

    • SC injections every 4 weeks for maintenance are available in a prefilled pen or prefilled syringe, so your patients can take Omvoh wherever is best for them!

    a For at least 30 minutes.
    IV=intravenous; SC=subcutaneous.

    References
    • Omvoh USPI October 2023.

    Stay informed with our latest updates

    From latest articles to infographics, we’ve got you covered. Explore what’s new and stay in the loop!

    Know more about the bowel urgency efficacy data

    Learn more about how Omvoh can help your UC patients with their most burdensome symptom

    Review the efficacy data of the LUCENT-2 trial

    Why Omvoh should be the prefered choice for patients with moderately to severely active UC

    Getting started with Omvoh from Induction to Maintenance

    Do you know about Omvoh dosing in moderate to severe patients with Ulcerative Colitis?

    Omvoh demonstrated durable clinical remission at Week 52

    64% of patients maintained clinical remission through 1 year of continuous treatment with Omvoh1

    Stay informed with our latest updates

    Learn more about how Omvoh can help your UC patients with their most burdensome symptom