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

Fact checked byMonica Stonehill

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.

Perspective from Katherine Falloon, MD

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.

Image: Healio — "We are working diligently with the FDA and hope to launch mirikizumab in the U.S. as soon as possible," Patrik Jonsson, Lilly executive vice president and president of Lilly Immunology and Lilly USA, said in a Eli Lilly press release.

“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.

Perspective

Katherine Falloon, MD

Over the past few years, the therapeutic armamentarium for inflammatory bowel disease has been expanding. In June 2022, risankizumab became the first interleukin-23 agent to be approved for the treatment of Crohn’s disease, but there is not yet a drug in this class approved for ulcerative colitis. However, there are a number of IL-23 inhibitors under study for UC, including mirikizumab.

Mirikizumab demonstrated promising results and a favorable safety profile in clinical trials for the treatment of UC. A recent study published in Clinical Translational Gastroenterology also demonstrated evidence for mucosal healing at a molecular level for the drug.

The FDA’s denial of the drug for UC reportedly was related to concerns with manufacturing, not efficacy or safety. However, it remains to be seen whether this decision will affect the medication’s release or whether another medication in the same class will gain approval first.

Overall, more choice for patients and prescribers in terms of therapeutic agents to treat IBD is of benefit, and it will be interesting to see where IL-23 agents, such as mirikizumab, will be positioned in patients with UC and in CD, should it gain approval for this indication as well.

Steere B, et al. Clin Transl Gastroenterol. 2023;doi:10.14309/ctg.0000000000000578.

Katherine Falloon, MD

PGY-7, Inflammatory Bowel Disease Fellow

Department of Gastroenterology, Hepatology and Nutrition

Digestive Disease & Surgery Institute

Cleveland Clinic

Disclosures: Falloon reports receiving funding from the Crohn’s and Colitis Foundation and serving on a GI Fellow Advisory Board for Janssen.

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