Posted by Michael Wonder on 13 Apr 2023
U.S. FDA issues complete response letter for mirikizumab
13 April 2023 - Eli Lilly announced the US FDA 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.
