STAT+: FDA approves Lilly ulcerative colitis treatment with a new approach to tamping down inflammation
The FDA approved Omvoh, an Eli Lilly drug that takes a new approach to treating ulcerative colitis, a chronic inflammatory disease.
The Food and Drug Administration on Thursday approved an Eli Lilly drug that takes a new approach to treating ulcerative colitis, a chronic inflammatory disease that can cause intense gastrointestinal pain and distress.
The therapy, dubbed Omvoh, is an antibody that blocks IL-23p19, an immune signaling molecule that plays a key role in sustaining the disease. It’s the first treatment to target this particular pathway in ulcerative colitis. The drug’s approval comes after two late-stage trials found that patients taking Omvoh showed a significant improvement in symptoms after both three months and a year compared with those given a placebo, and that the therapy had minimal side effects.
Omvoh’s list price will be $9,593 per month for intravenous delivery and $10,360 per dose injected beneath the skin. A company spokesperson told STAT that patients who have the drug covered by commercial insurance may pay as little as $5 per month for up to 30 months.
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