FDA rejects Eli Lilly’s mirikizumab for ulcerative colitis, citing manufacturing concerns

The FDA issued a complete response letter to Eli Lilly indicating it cannot approve the company’s biologic license application seeking approval for mirikizumab as a treatment for ulcerative colitis.In its letter, the FDA cited concerns over the proposed manufacturing of mirikizumab, a first-in-class monoclonal antibody selectively targeting the IL-23 p19 subunit; however, the agency reported no issues regarding the clinical data package, safety or label for the drug.“We remain confident in mirikizumab’s pivotal phase 3 clinical data and its potential to help people withRead More