U.S. Food and Drug Administration Issues Complete Response Letter for Mirikizumab Eli Lilly and Company (NYSE: LLY) announced the U.S. Food and Drug Administration (FDA) has issued a complete response letter for the mirikizumab...

INDIANAPOLIS , April 13, 2023 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY ) announced the U.S. Food and Drug Administration (FDA) has issued a complete response letter for the mirikizumab biologic license application (BLA) for the treatment of ulcerative colitis (UC). In the letter, the FDA cited issues related to the proposed manufacturing of mirikizumab, with no concerns about the clinical data package, safety, or label for the medicine.

"We remain confident in mirikizumab's pivotal Phase 3 clinical data and its potential to help people with ulcerative colitis," said Patrik Jonsson , Lilly executive vice president, president of Lilly Immunology and Lilly USA , and chief customer officer. "We are working diligently with the FDA and hope to launch mirikizumab in the U.S. as soon as possible."

Cautionary Statement Regarding Forward-Looking Statements

This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about mirikizumab, FDA approval, and Lilly's products, and reflects Lilly's current beliefs and expectations. However, as with any such undertaking, there are substantial risks and uncertainties in the process of drug research, development, and commercialization. Among other things, there is no guarantee that future study results will be consistent with study findings to date, that future study results will be consistent with study results to date, that mirikizumab will receive certain regulatory approvals, or that it will be commercially successful. For further discussion of these and other risks and uncertainties, see Lilly's Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly undertakes no duty to update forward-looking statements to reflect events after the date of this release.

SOURCE Eli Lilly and Company