FDA Declines to Approve Lilly’s Ulcerative Colitis Drug

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The FDA cited issues related to the proposed manufacturing of the drug, mirikizumab. Lilly expressed confidence that they could be corrected.

Although the FDA declined to approve Eli Lilly’s biologic license application (BLA) for mirikizumab to treat ulcerative colitis (UC) over manufacturing concerns, the company still expects to launch the medicine in the U.S. soon.

In the letter, the FDA cited issues related to the proposed manufacturing of mirikizumab, with no concerns about the safety or efficacy of the medicine, Lilly said.



Patrik Jonsoon is executive vice president of Eli Lilly;  president of Lilly Immunology;  president of Lilly USA; and chief customer officer.

Patrik Jonsoon is executive vice president of Eli Lilly; president of Lilly Immunology; president of Lilly USA; and chief customer officer.

"We remain confident in mirikizumab's pivotal Phase 3 clinical data and its potential to help people with ulcerative colitis," said Patrik Jonsson, executive vice president of Lilly, president of Lilly Immunology and Lilly USA, and chief customer officer in a news release. "We are working diligently with the FDA and hope to launch mirikizumab in the U.S. as soon as possible.”

Lilly is “working closely with the FDA to address and resolve observations that were noted following the agency’s recent pre-approval inspection for mirikizumab,” Carla Cox, communications director for Lilly, told Formulary Watch. “We remain confident in mirikizumab’s efficacy and safety profile, which is supported by our pivotal Phase 3 clinical data.”

The supporting information Lilly submitted to the FDA included the Phase 3 LUCENT-1 and LUCENT-2 studies. In the LUCENT-2 study, patients with ulcerative colitis (UC) who responded to mirikizumab at 12 weeks achieved and maintained statistically superior and clinically meaningful improvements at one year compared to placebo across the primary endpoint of clinical remission and all key secondary endpoints, including bowel urgency severity, using a novel, patient-reported outcome measure, Lilly said.

Among patients who had responded to 12-week induction treatment with mirikizumab, one-half (49.9%) of patients receiving mirikizumab maintenance treatment achieved clinical remission at one year compared to 25.1% of patients on placebo. Nearly two-thirds (63.6%) of patients receiving mirikizumab who achieved clinical remission at 12 weeks maintained clinical remission at one year (63.6%) compared to approximately one-third (36.9%) of patients on placebo.

Drug regulators elsewhere have approved mirikizumab or seem ready to do so. Lilly recently announced that Japan’s drug approval agency approved mirikizumab as a first-in-class treatment for adults with moderately to severely active UC. The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for mirikizumab as a first-in-class treatment for adults with moderately to severely active UC who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic treatment.

The company expects regulatory decisions in additional markets around the world in 2023.

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