US FDA Shoots Down Eli Lilly’s Application for Ulcerative Colitis Drug

April 14, 2023

The US Food and Drug Administration (FDA) has declined to approve Eli Lilly’s ulcerative colitis drug mirikuzimab. The agency credits manufacturing issues for the decision, noting that the drugs efficacy and safety are not in question. A Lilly spokesperson said that they are working closely with the agency to address these problems and bring the drug to market.

According to Drew Armstrong, “The market for ulcerative colitis is large — the National Institutes of Health estimates that there are around 600,000 to 900,000 patients in the US. But it’s also crowded with treatments that include well-established antibodies such as AbbVie’s Humira, and other drugs that also target IL-23, including AbbVie’s Skyrizi and Janssen’s Stelara.”

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