Mirikizumab (OMVOH) is designed for adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic treatment.
In addition, the treatment is the first IL-23p19 targeted biologic to demonstrate efficacy for induction and maintenance therapy of moderately to severely active ulcerative colitis.
Marketing authorisation was based on two randomised, double-blind, placebo-controlled phase 3 trials, LUCENT-1 and LUCENT-2. In both studies mirikizumab achieved primary and key secondary endpoints, including sustained clinical remission.
Patients treated with mirikizumab achieved a greater reduction in rectal bleeding and stool frequency subscores as early as two weeks.
The LUCENT studies also investigated endpoints such as bowel urgency remission and bowel urgency severity using the validated Urgency Numeric Rating Scale (NRS).
Decreases in bowel urgency severity were observed as early as two weeks in patients treated with mirikizumab. After treatment with mirikizumab, 42.9% of patients achieved bowel urgency remission at one year, compared to 25% of placebo.
Laura Steele, president and general manager, Northern Europe, Eli Lilly and Company, said: “This authorization establishes mirikizumab as the first IL-23p19 antagonist to be authorized in Great Britain for the treatment of adults with moderate to severe Ulcerative Colitis and reflects our commitment to immunological diseases with high unmet need.”
“We understand the importance of having novel treatment options for eligible patients and Lilly would like to thank the patients and investigators around the world who have made this possible.”
Professor Jimmy Limdi, Gastroenterology, University of Manchester added: “Ulcerative colitis is a chronic, relapsing inflammatory disorder affecting the large intestine. It is characterized by symptoms of diarrhea, bleeding and urgency, with multidimensional, and often negative effects on patients’ personal, psychological, professional and social well-being. Our understanding of the aetio-pathogenesis is improving, but our treatment options remain limited.”
“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.”