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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. Lilly's Mirikizumab Helps Patients Achieve Clinical Remission and Improves Symptoms in Adults with Ulcerative Colitis in 12-Week Phase 3 Induction Study 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). Advise patients to discontinue OMVOH and seek immediate medical attention if they experience any symptoms of serious hypersensitivity reactions [see WARNINGS AND PRECAUTIONS]. Infections 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. 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.

FDA rejects Eli Lilly's ulcerative colitis prospect mirikizumab, citing manufacturing shortfalls". Fierce Pharma. 14 April 2023. Archived from the original on 26 April 2023 . Retrieved 26 April 2023. upper respiratory tract infections (e.g., COVID-19, runny or stuffy nose, sore throat, sinus infection), Ministère de I’Enseignement Primaire, Secondaire, Technique et de I’Alphabétisation, République Centrafricaine (1)achieved histologic-endoscopic mucosal improvement compared to 14% of placebo (n=200/795 vs, n=38/267) Instruct patients or caregivers to administer two 100 mg prefilled pens to achieve the full 200 mg dose of OMVOH. Nonclinical Toxicology Carcinogenesis, Mutagenesis, Impairment Of Fertility Ministère de l'Éducation Nationale, de la Formation Professionnelle, de l'Enseignement Supérieur et de la Recherche Scientifique, Royaume du Maroc (1) In addition, the premium feel of the MRKZ sketchbook is naturally enhanced by it's high quality pencil grey fabric bookcloth covering off-set by a contrasting Wibalin plum coloured lining - perfect for any professional context. Adverse effects associated with the use of Omvoh may include, but are not limited to, the following:

Table 1: Adverse Reactions a in Subjects with Ulcerative Colitis through Week 12 in a Placebo-Controlled Induction Study (UC-1) Adverse Reactions The approval was based on results from the LUCENT program , which included two randomized, double-blind, placebo-controlled Phase III 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. Omvoh contains mirikizumab-mrkz, whichworks to reduce inflammation in ulcerative colitis by selectively targeting the p19 subunit of IL-23 to inhibit the IL-23 pathway. Severe headache,confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors. Obtain liver enzymes and bilirubin levels prior to initiating treatment with OMVOH [see WARNINGS AND PRECAUTIONS].a b "FDA Approves Lilly's Omvoh (mirikizumab-mrkz), A First-in-Class Treatment for Adults with Moderately to Severely Active Ulcerative Colitis". BioSpace . Retrieved 30 October 2023. At Week 104, 75% of Patients with Ulcerative Colitis Taking Mirikizumab Maintained Symptomatic Remission in Phase 2 Study

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. FDA approval of Omvoh 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. 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).Approval FDA Approves Omvoh (mirikizumab-mrkz), a First-in-Class Treatment for Adults with Moderately to Severely Active Ulcerative Colitis OMVOH was studied up to 12 weeks in subjects with moderately to severely active ulcerative colitis in a randomized, double-blind, placebo-controlled induction study (UC-1). In subjects who responded to induction therapy in UC-1, long term safety up to 52 weeks was evaluated in a randomized, double-blind, placebo-controlled maintenance study (UC-2) and a long-term extension study [see Clinical Studies].

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."

Development timeline for Omvoh

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. "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." The safety and effectiveness of Omvoh have not been established in pediatric patients. What Drugs, Substances, or Supplements Interact with Omvoh? Table 2 summarizes the adverse reactions reported in at least 2% of subjects and at a higher frequency than placebo during the 40-week controlled period of UC-2. Inform patients that OMVOH may cause liver injury. Advise patients to seek immediate medical attention if they experience symptoms suggestive of liver dysfunction (e.g., unexplained rash, nausea, vomiting, abdominal pain, fatigue, anorexia, or jaundice and/or dark urine) [see WARNINGS AND PRECAUTIONS]. Immunizations