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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 past history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Monitor patients for signs and symptoms of active TB during and after OMVOH treatment. a b "FDA Approves Lilly's Omvoh (mirikizumab-mrkz), A First-in-Class Treatment for Adults with Moderately to Severely Active Ulcerative Colitis" (Press release). Eli Lilly and Company . Retrieved 30 October 2023– via PR Newswire. OMVOH is indicated for the treatment of moderately to severely active ulcerative colitis in adults. DOSAGE AND ADMINISTRATION Recommended Evaluations And Immunizations Prior To Treatment Initiation Transport of endogenous IgG antibodies across the placenta increases as pregnancy progresses, and peaks during the third trimester. Because mirikizumab-mrkz may interfere with immune response to infections, risks and benefits should be considered prior to administering live vaccines to infants exposed to OMVOH in utero. There are no data regarding infant serum levels of mirikizumab-mrkz at birth and the duration of persistence of mirikizumab-mrkz in infant serum after birth. Although a specific timeframe to delay live virus immunizations in infants exposed in utero is unknown, a minimum of 2 months after birth should be considered because of the half-life of the product. Data The recommended induction dosage of OMVOH is 300 mg administered by intravenous infusion over at least 30 minutes at Week 0, Week 4, and Week 8 [see DOSAGE AND ADMINISTRATION]. Maintenance Dosage
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. 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." OMVOH is a clear to opalescent, colorless to slightly yellow to slightly brown solution available as:
Omvoh achieved primary and key secondary endpoints, including sustained clinical remission in pivotal trials. Omvoh™ is indicated for the treatment of moderately to severely active ulcerative colitis in adults. Omvoh (mirikizumab-mrkz) is an interleukin-23 antagonist indicated for the treatment of moderately to severely active ulcerative colitis in adults.
No organ weight or histopathology effects were observed in the male or female reproductive tract in sexually mature cynomolgus monkeys that received subcutaneous mirikizumab-mrkz once weekly for 26 weeks, at a dose of 100 mg/kg (at least 7 times the MRHD of mirikizumab-mrkz, based on exposure comparisons). Use In Specific Populations Pregnancy Pregnancy Exposure Registry Do not initiate treatment with OMVOH in patients with a clinically important active infection until the infection resolves or is adequately treated. The FDA approval of Omvah 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. Ulcerative colitis (UC) is a chronic inflammatory bowel disease characterized by inflammation and ulcers on the inner lining of the large intestine. The inflammation in UC is thought to be caused in part by overactivation of the interleukin-23 (IL-23) pathway.Lilly's Mirikizumab Helps Patients Achieve Clinical Remission and Improves Symptoms in Adults with Ulcerative Colitis in 12-Week Phase 3 Induction Study" (Press release). Eli Lilly and Company . Retrieved 30 October 2023– via PR Newswire. 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. 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. 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. Adverse effects associated with the use of Omvoh may include, but are not limited to, the following:
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