The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorisation to Eli Lilly’s mirikizumab for moderately to severely active ulcerative colitis.
The drug is approved in adult patients who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic treatment.
“Ulcerative colitis is a chronic, relapsing inflammatory disorder affecting the large intestine. Our understanding of the aetio-pathogenesis is improving, but our treatment options remain limited,” said Professor Jimmy Limdi, Consultant Gastroenterologist/Head of IBD Section at Northern Care Alliance NHS Foundation Trust and Professor of Gastroenterology at University of Manchester.
“The recent authorisation of mirikizumab, the first IL-23p19 inhibitor, is positive news for eligible people living with ulcerative colitis and gastroenterologists/specialists caring for them. It is a significant scientific advance welcomed by the medical community.”
The authorisation was based on results from the LUCENT program, which included two randomised, double-blind, placebo-controlled Phase III clinical trials, consisting of one 12-week induction study (LUCENT-1) and one 40-week maintenance study (LUCENT-2) for 52 weeks of continuous treatment.
In the LUCENT-1 induction study, after 12 weeks of treatment with mirikizumab 24.2% of patients achieved the primary endpoint of clinical remission compared to 13.3% for placebo.
544 patients who achieved a clinical response with mirikizumab in LUCENT-1 were re-randomised 2:1 to receive mirikizumab (200mg) or placebo for another 40 weeks in LUCENT-2.
Of the LUCENT-1 patients who achieved clinical response at 12 weeks, 49.9% achieved clinical remission and 43.3% (n=158/365) achieved histologic-endoscopic mucosal remission at one year, compared to placebo (25.1 and 21.8% respectively).
After treatment with mirikizumab, 42.9% of patients achieved bowel urgency remission at one year, compared to 25% of placebo.
