On Oct. 26, 2023, the U.S. Food and Drug Administration (FDA) approved Eli Lilly and Company’s Omvoh™ (mirikizumab-mrkz) injection. Indicated to treat adults who have active moderate to severe ulcerative colitis (UC), it interferes with the p19 subunit of interleukin-23 (IL-23p19) to lessen intestinal inflammation. Dosing is in two stages – after three 300mg intravenous (IV) doses are given by a healthcare provider once every month, treatment shifts to monthly doses of 200mg administered subcutaneously (SC). Patients and caregivers will be able to inject SC doses of Omvoh. The wholesale acquisition cost (WAC) for one IV dose is $9,593 and for one SC dose (as two 100mg injections given at the same time) is $10,360. The launch is expected in the coming weeks. Here is the full prescribing information.
At a Glance
- Brand (Generic) Name: Omvoh (mirikizumab-mrkz)
- Manufacturer: Eli Lilly
- Date Approved: Oct. 26, 2023
- Indication: to treat moderately to severely active UC in adults.
- Dosage Forms Available: single-dose vials containing 300mg/15mL of solution for dilution and IV infusion and single-dose pens prefilled with 100mg/mL solution for SC injection
- Launch Date: in the coming weeks
- Estimated Annual Cost: For the first year of therapy, WAC is approximately $122,000.
- UC is an autoimmune inflammatory bowel disease (IBD) that damages the lining of the large intestine and rectum.
- According to the Crohn’s and Colitis Foundation, more than 900,000 patients in the U.S. have UC, and about 38,000 new patients are diagnosed, annually.
- Many symptoms of IBDs, such as fatigue, fever, and weight loss, can be vague and general. More specific symptoms can include bowel urgency, rectal bleeding, and the feeling that the bowels have not emptied fully. The severity of symptoms also tends to be irregular and unpredictable.
- By inhibiting the activity of the p19 subunit of IL-23, Omvoh reduces the release of substances that cause inflammation of the intestines.
- Following three months of treatment in a clinical study, 65% of patients using Omvoh had at least some relief of symptoms, with 24% seeing symptoms entirely resolved. In the placebo group, 43% had a response and 15% responded completely.
- One-half of the patients who responded to the IV induction treatment did not need to use steroids to maintain remission for the 40-week-long follow-up period.
- The most common side effects associated with Omvoh include headaches, injection site reactions, joint pain, rash, and upper respiratory infections (URI). More serious adverse events may include hypersensitivity reactions, liver damage, and increased risk of infections.
- Stelara® (ustekinumab) targets IL-23 and also interleukin-12 (IL-12) to treat UC.
- Skyrizi™ (risankizumab-rzaa) is an IL-23 inhibitor that is approved for Crohn’s disease, the other type of IBD. It’s also approved for psoriasis and psoriatic arthritis. Approval of Skyrizi for UC is expected in June 2024. Other FDA-approved IL-23 inhibitors are indicated for treating psoriasis and other inflammatory conditions, but not UC or Crohn’s disease.
- Several other therapy classes, such as antibiotics, corticosteroids, immunomodulators, and 5-aminosalicylic acids (5-ASAs), are used to treat UC. Tumor necrosis factor (TNF) blockers, including adalimumab (Humira®/biosimilars) also are used, as is Entyvio® (vedolizumab), an integrin receptor antagonist that prevents certain types of white blood cells from increasing intestinal inflammation. Oral S1P inhibitors, Velsipity™ (etrasimod) and Zeposia® (ozanimod) also have been FDA approved for treating UC.