Eli Lilly receives complete response letter from FDA for mirikizumab

Eli Lilly announced the Food and Drug Administration has issued a complete response letter for the mirikizumab biologic license application for the treatment of ulcerative colitis. 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, the company said in a statement. "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."