Mirikizumab Approval Denied Over Issues Related to Proposed Manufacturing

The Food and Drug Administration (FDA) has issued a Complete Response Letter to Eli Lilly regarding the Biologics License Application for mirikizumab, an investigational anti-IL-23p19 monoclonal antibody, for the treatment of ulcerative colitis (UC).

According to Lilly, the application was rejected because of issues related to the proposed manufacturing of mirikizumab and not due to safety or efficacy concerns. The mirikizumab clinical trial program includes 3 UC trials:  the LUCENT-1 induction study (ClinicalTrials.gov Identifier: NCT03518086), the LUCENT-2 maintenance study (ClinicalTrials.gov Identifier: NCT03524092), and the LUCENT-3 open-label extension study (ClinicalTrials.gov Identifier: NCT03519945).

In the induction study, mirikizumab met both the primary (clinical remission based on modified Mayo Score at week 12; P <.0001) and key secondary endpoints (reduced bowel urgency; clinical response; endoscopic remission, symptomatic remission, improvement in endoscopic histologic inflammation) when compared with placebo.

In the maintenance trial, patients who achieved clinical response in the induction study were randomly assigned to mirikizumab maintenance dosing or placebo for 40 weeks. Results showed that a statistically higher proportion of patients treated with mirikizumab achieved clinical remission at 1 year compared with those who received placebo (P <.001).

“We remain confident in mirikizumab’s pivotal phase 3 clinical data and its potential to help people with ulcerative colitis,” said Patrik Jonsson, Lilly executive vice president, president of Lilly Immunology and Lilly USA, and chief customer officer. “We are working diligently with the FDA and hope to launch mirikizumab in the US as soon as possible.”