Omvoh From Eli Lilly and Company

The FDA has approved mirikizumab-mrkz injection (Omvoh) from Eli Lilly and Company for the treatment of moderately to severely active ulcerative colitis (UC) in adults.¹ Key symptoms of UC can include bowel urgency, rectal bleeding, and stool frequency, with bowel urgency reported as one of the most disruptive symptoms.²

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PHARMACOLOGY AND PHARMACOKINETICS

Mirikizumab-mrkz is an IL-23 antagonist that selectively binds to the p19 subunit of IL-23 to inhibit the release of proinflammatory cytokines and chemokines. It displays linear pharmacokinetics and reaches maximum plasma concentration 5 days after subcutaneous administration. Mirikizumab-mrkz has an elimination half-life of 9.3 days.^1,2

DOSAGE AND ADMINISTRATION

The recommended induction dose of mirikizumab-mrkz is a 300-mg intravenous infusion over at least 30 minutes at weeks 0, 4, and 8. The recommended maintenance dose is 200 mg subcutaneously (given as 2 consecutive injections of 100 mg) at week 12 and every 4 weeks thereafter.

Before beginning treatment with mirikizumab-mrkz, patients should be evaluated for tuberculosis (TB) infection, bilirubin levels and liver enzymes should be obtained, and all age-appropriate vaccinations should be completed according to current immunization guidelines. Mirikizumabmrkz is supplied as a 300-mg/15-mL solution in a singledose vial for preparation of the intravenous infusion and as a 100-mg/mL solution in a single-dose, prefilled pen for subcutaneous administration.¹

CLINICAL TRIALS

Mirikizumab-mrkz was evaluated in 2 double-blind, placebocontrolled, randomized studies in adults with moderately to severely active UC who had inadequate response, loss of response, or who failed to tolerate 6-mercaptopurine, azathioprine, biologic therapy, corticosteroids, or tofacitinib. LUCENT 1 (NCT03518086) was a phase 3, 12-week intravenous induction study that was followed by LUCENT 2 (NCT03524092), a phase 3, 40-week maintenance study. Participants in LUCENT 1 were randomly assigned 3:1 to receive mirikizumab-mrkz 300 mg or placebo at weeks 0, 4, and 8. Participants using mirikizumab-mrkz in LUCENT 1 who achieved clinical response at week 12 were randomly assigned 2:1 to receive mirikizumab-mrkz 200 mg or placebo subcutaneously every 4 weeks for 40 weeks in LUCENT 2.

Both LUCENT 1 and LUCENT 2 met their primary end point, which was clinical remission at week 12. The secondary end points met in LUCENT 1 were clinical response, endoscopic improvement, and histologicendoscopic mucosal improvement (HEMI). LUCENT 2 met its secondary end points, which were corticosteroid-free clinical remission, endoscopic improvement, HEMI at 40 weeks, and maintenance of clinical remission in participants who achieved clinical remission at 12 weeks. Both studies also demonstrated improvements in bowel urgency in the mirikizumab-mrkz group as compared with placebo.^1,2

CONTRAINDICATIONS, WARNINGS, AND PRECAUTIONS

Treatment with mirikizumab-mrkz is contraindicated in patients with a history of serious hypersensitivity reaction to the medication or any of its components. Serious hypersensitivity reactions, including anaphylaxis and infusion-related reactions, have occurred. If a severe hypersensitivity reaction occurs, the medication should be discontinued and appropriate treatment initiated.¹

Treatment with mirikizumab-mrkz may increase the risk of infection and should not be used in patients with a clinically important active infection. Mirikizumab-mrkz should not be used in patients with active TB. Patients should be monitored for signs and symptoms of active TB during and after treatment.¹

Drug-induced liver injury has been reported. Bilirubin levels and liver enzymes should be monitored at baseline and for at least 24 weeks during treatment and thereafter according to routine patient management. Treatment should be interrupted if drug-induced liver injury is suspected. The use of live vaccines should be avoided.¹

The most common adverse reactions with the induction dose are arthralgia and upper respiratory tract infections. The most common adverse reactions with the maintenance dose are arthralgia, headache, herpes viral infection, injection site reactions, rash, and upper respiratory tract infections.¹

References

1. Omvoh. Prescribing information. Eli Lilly and Company; 2023. Accessed February 5, 2024. https://pi.lilly.com/us/omvoh-uspi.pdf?s=pi

2. FDA approves Lilly’s Omvoh (mirikizumab-mrkz), a first-in-class treatment for adults with moderately to severely active ulcerative colitis. News release. Eli Lilly and Company. October 26, 2023. Accessed February 5, 2024. https://investor.lilly.com/news-releases/news-release-details/fda-approves-lillys-omvohtm-mirikizumab-mrkz-first-class