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

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 with ulcerative colitis,” Patrik Jonsson, Lilly executive vice president and president of Lilly Immunology and Lilly USA, said in company press release. “We are working diligently with the FDA and hope to launch mirikizumab in the U.S. as soon as possible.”

Eli Lilly had filed for regulatory approval based on positive results from the phase 3 LUCENT-1 and LUCENT-2 studies, as well as the ongoing LUCENT-3, a long-term extension study evaluating the drug’s safety and efficacy, and SHINE-1, which is assessing the drug in pediatric patients.

Eli Lilly reported that mirikizumab has procured regulatory approval in Japan for adults with moderate-to-severe active UC and is presently under review by the EMA following a positive CHMP recommendation, with a decision expected in 2023. The company has not mentioned whether the manufacturing concerns noted by the FDA will impact regulatory decisions for mirikizumab as the third IL-23 inhibitor for Crohn’s disease.

April 14, 2023


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