Omvoh Now Approved

The first approved IL-23p19 inhibitor for moderate to severe ulcerative colitis patients^1,2

Omvoh Now Approved

The first approved IL-23p19 inhibitor for moderate to severe ulcerative colitis patients^1,2

Omvoh Now Approved

Omvoh the first approved IL-23p19 inhibitor for moderate to severe ulcerative colitis patients^1,2

Omvoh Now Approved

Omvoh the first approved IL-23p19 inhibitor for moderate to severe ulcerative colitis patients^1,2

Omvoh Now Approved

Omvoh the first approved IL-23p19 inhibitor for moderate to severe ulcerative colitis patients^1,2

Omvoh Now Approved

Omvoh the first approved IL-23p19 inhibitor for moderate to severe ulcerative colitis patients^1,2

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 52^1,3,4

Well Tolerated Safety Profile from Two Phase 3 Trials

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

Considering a different treatment for your UC patients?

Dr. Peter Irving discusses how patients achieved clinical remission with Omvoh in the LUCENT trialWATCH NOW

If you look at the efficacy data from the LUCENT trials, Omvoh demonstrated superiority compared to placebo on all primary and key secondary endpoints.

– Dr. Peter Irving

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

download now

learn more

Review the efficacy data of the LUCENT-2 trial

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

download now

learn more

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.

PP-MR-AE-0079 Privacy Policy Prescribing information

For adverse events and safety reporting, please send an email: PV-MEA@lilly.com, For product complaints, please send an email: lbmail_pc_mena@lilly.com For further information about Lilly and Lilly products please contact us at the below address: UAE: Bldg. 25 - 6th Floor, Dubai Health CareCity, Dubai, UAE, P.O. Box #25319, Tel.: (+971 4)453 7800, Fax: (+971 4) 436 2399This content is approved by Eli Lilly and company (“Lilly”).

This content is intellectual property of Lilly and its reproduction needs Lilly's prior permission

Lilly and Omvoh^TM are registered trademarks of Eli Lilly and Company.
©2024 Eli Lilly and Company. All Rights Reserved.

“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

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 time^3,4

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

PP-MR-AE-0079 Privacy Policy Prescribing information

Omvoh-A first-in-class IL-23p19 antagonist for the treatment of moderately to severely UC^1-3

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 responses^1,4

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 trials^1,3

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 biologic^1-4

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.

PP-MR-AE-0079 Privacy Policy Prescribing information

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 Omvoh^{2, 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 data^{1, 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.

PP-MR-AE-0079 Privacy Policy Prescribing information

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 8^b

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!

PP-MR-AE-0079 Privacy Policy Prescribing information

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

download now

learn more

Review the efficacy data of the LUCENT-2 trial

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

download now

learn more

Stay informed with our latest updates

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

3:26 min

Addressing Bowel Urgency in Patients with Ulcerative Colitis

3:26 min

The first IL-23p19 antagonist for ulcerative colitis in adults

3:26 min

Patient Instructions - How to Inject?

PP-MR-AE-0079 Privacy Policy Prescribing information

Omvoh Now Approved

Omvoh Now Approved

Omvoh Now Approved

Omvoh Now Approved

Omvoh Now Approved

Omvoh Now Approved

Make the Urgent Change with Omvoh

Sustained Clinical Remission

Reduces the Disruptive Impact of Bowel Urgency

Well Tolerated Safety Profile from Two Phase 3 Trials

Considering a different treatment for your UC patients?

– Dr. Peter Irving

Latest Updates

Know more about the bowel urgency efficacy data

Review the efficacy data of the LUCENT-2 trial

References

Mia

Mia

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

References

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

References

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

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

PRIOR THERAPIES

Of the 479 patients in LUCENT-1 who failed a prior biologic or tofacitinib4:

Of the 192 patients in LUCENT-2 who failed a prior biologic or tofacitinib3:

References

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

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

References

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

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

References

Getting started with Omvoh

START WITH INFUSIONS

START WITH INFUSIONS

Stay informed with our latest updates

Know more about the bowel urgency efficacy data

Review the efficacy data of the LUCENT-2 trial

Stay informed with our latest updates

3:26 min

Addressing Bowel Urgency in Patients with Ulcerative Colitis

3:26 min

The first IL-23p19 antagonist for ulcerative colitis in adults

3:26 min

Patient Instructions - How to Inject?

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

Omvoh-A first-in-class IL-23p19 antagonist for the treatment of moderately to severely UC^1-3

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

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

Of the 479 patients in LUCENT-1 who failed a prior biologic or tofacitinib⁴:

Of the 192 patients in LUCENT-2 who failed a prior biologic or tofacitinib³:

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

The majority of injection-site reactions were mild to moderate and did not lead to discontinuation of Omvoh^{2, 3}

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

The safety profile of Omvoh at 2 years is consistent with earlier data^{1, 2}