Eli Lilly and Co said on Thursday that the U.S. Food and Drug Administration (FDA) had declined to approve its drug to treat a type of chronic inflammatory bowel disease in adults.
The health regulator cited issues related to the proposed manufacturing of the drug, mirikizumab, although it did not express concerns about the clinical data package, safety, or label for the medicine, Lilly said.
"The setback is fairly minor from the context of what a great portfolio Eli Lilly has and even within the drug itself, it sounds like it's manufacturing issues, so I don't think that's going to be overly problematic," Morningstar analyst Damien Conover told Reuters. "There is still possibility this product can exceed $2 billion peak sales," Wells Fargo analyst Mohit Bansal said in a note.an accelerated nod for Lilly's Alzheimer's disease drug, donanemab, potentially preventing the company from expediting the launch.
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