FDA Issues Complete Response Letter for Eli Lilly's Mirikizumab BLA in Ulcerative Colitis Due to Manufacturing Concerns

On April 13, Eli Lilly announced that it had received a Complete Response Letter (CRL) from the FDA regarding the Biologics License Application (BLA) for mirikizumab for the treatment of moderate to severe ulcerative colitis (UC). Eli Lilly's press release noted that the reason for the rejection was that the FDA had some questions about the proposed manufacturing process for mirikizumab, and emphasized that the FDA has no concerns regarding the drug’s clinical data, safety, or labeling.

Ulcerative colitis is a common type of inflammatory bowel disease that causes abnormal inflammation on the inner surface of the rectum and colon, leading to open ulcers in the large intestine. The most common symptoms include abdominal pain, cramps, and frequent diarrhea, often with blood, pus, or mucus in the stool. Additionally, symptoms such as nausea, loss of appetite, fatigue, and fever may occasionally occur.

Mirikizumab is a humanized IgG4 monoclonal antibody that binds to the p19 subunit of IL-23, thereby blocking IL-23-mediated inflammatory responses. The Phase III LUCENT-1 study showed that after 12 weeks of treatment, mirikizumab vs. placebo achieved clinical remission (p<0.0001) as the primary endpoint. Additionally, mirikizumab also met all key secondary endpoints, including reduced bowel urgency, clinical response, endoscopic remission, symptom relief, and endoscopic histologic inflammation.

Phase III LUCENT-2 Study Shows Nearly Half (n=182/365) of Patients Achieved Clinical Remission After One Year of Mirikizumab Maintenance Therapy, Compared to the Placebo Group (n=45/179, p<0.001); Of Those Who Achieved Clinical Remission at Week 12, 63.6% (n=91/143) Maintained Benefit at One Year, Significantly Outperforming the Placebo Group (36.9%, n=24/65, p<0.001).

Notably, mirikizumab demonstrated superior efficacy compared to Novartis' Cosentyx (secukinumab) in a Phase III study for the treatment of plaque psoriasis. However, during the release of its Q1 2021 financial report, Eli Lilly announced that it had withdrawn the regulatory application for mirikizumab in this indication and decided to focus its efforts on ulcerative colitis and Crohn's disease. Currently, the clinical study for Crohn’s disease has progressed to Phase III.

Patrik Jonsson, Senior Vice President of Eli Lilly, President of Eli Lilly Immunology, and President and Chief Customer Officer of Eli Lilly USA, said: "We are confident in the pivotal Phase III clinical data of mirikizumab and its potential to treat patients with ulcerative colitis. We are working diligently with the FDA and hope to bring mirikizumab to the U.S. market as soon as possible."

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