Surprise setback for mirikizumab as US regulator denies approval

14 April 2023

An important regulatory submission from Eli Lilly (NYSE: LLY) has not been successful, with the US regulator issuing a complete response letter (CRL) for mirikizumab in ulcerative colitis.

The rebuff will set back the timeline for approval, with questions being raised in relation to the proposed manufacturing process.

The US Food and Drug Administration did not raise any concerns regarding the data package or safety of the medicine, Lilly said in a statement.

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