FDA declines Eli Lilly’s bowel disease drug over manufacturing issues

pharmafile | April 14, 2023 | News story | Manufacturing and Production  

Pharma giant Eli Lilly’s Biologic Licence Application (BLA) for its bowel disease drug has been declined by the FDA over concerns about the proposed manufacturing of the drug. However, concerns weren’t expressed over the clinical data package, safety or label for the medicine.


Mirikizumab was hoped to become a new drug treatment for ulcerative colitis (UC), a condition where abnormal reactions in the immune system cause inflammation in the inner lining of the colon. Rivals such as AbbVie, Pfizer and Johnson & Johnson already have drugs in the $20bn market.


Lilly recently received approval in Japan for the use of mirikizumab in adult patients with moderately to severely active UC. The EMA’s Committee for Medicinal Products for Human Use (CHMP) also issued a positive opinion for mirikizumab in adults with moderately to severely active UC who have had an inadequate response with, lost response to or were intolerant to either conventional therapy or biologic treatment.


Patrik Jonsson, Lilly’s executive vice president, president of Lilly Immunology and Lilly USA and chief customer officer stated: “We remain confident in mirikizumab’s pivotal phase 3 clinical data and its potential to help people with UC. We are working diligently with the FDA and hope to launch mirikizumab in the US as soon as possible.”


James Spargo

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