Jan. 16, 2025 – The FDA has approved the drug Omvoh for treating adults with moderately to severely active Crohn's disease, a type of chronic inflammatory bowel disease. This marks the second approved indication for Omvoh in the U.S. for inflammatory bowel disease, after its October 2023 approval as a first-in-class treatment for adults with moderately to severely active ulcerative colitis.
in the U.S., about a million people are affected by Crohn's disease, a long-term illness in which the immune system attacks bacteria in the intestines, causing inflammation in the digestive tract. It mostly affects the small and large intestines but can happen anywhere from mouth to anus. Symptoms include stomach pain, diarrhea, fatigue, nausea, joint pain, and fever, with flare-ups followed by periods of remission. The condition can also lead to stress, depression, and anxiety, which can worsen symptoms.
Omvoh (generic name mirikizumab) is a monoclonal antibody that works by activating the body’s immune system to fight disease. According to a news release from Eli Lilly, the drug’s maker, Omvoh blocks a special protein called interleukin-23p19 (IL-23p19), part of the IL-23 pathway that is involved in Crohn’s disease inflammation, thereby relieving symptoms. The company explained that patients will receive the first three doses as an IV infusion at a health care facility every four weeks, with each session lasting about 90 minutes. Later, after they're trained to do so, patients will give themselves Omvoh maintenance doses with shots under the skin every four weeks.
The FDA approval was based on a clinical trial that showed Omvoh worked better than a placebo in treating moderate to severe Crohn's disease in people who didn’t respond to other treatments. After one year, 53% of people treated with Omvoh had significant symptom relief, compared to 36% on a placebo. Also, 46% of people treated with Omvoh showed visible healing of their intestinal lining, compared to 23% of those on a placebo.
Omvoh’s safety profile in patients with moderate to severe Crohn’s disease aligns with previous findings in patients with ulcerative colitis. The most common side effects include upper respiratory tract infections, reactions where people got the shot, headaches, joint pain, and elevated liver enzyme levels. Omvoh’s label warns about allergic reactions, increased risk of infections, and liver issues. Patients must inform their health care provider if they have any active or ongoing infections (particularly tuberculosis) or liver diseases. They must avoid getting vaccinated with live vaccines before, during, and right after treatment. Women must inform their doctors if they are pregnant, planning to get pregnant, or breastfeeding before starting Omvoh.
