Eli Lilly receives UK approval for ulcerative colitis treatment
As a result, mirikizumab has become the first IL-23p19 targeted biologic recommended by NICE for use within NHS England and Wales for UC.
The recommendation was based on the results from the LUCENT program, encompassing two randomized, double-blind, placebo-controlled phase 3 trials, LUCENT-1 and LUCENT-2, in which mirikizumab achieved primary and key secondary endpoints, including sustained clinical remission.
These trials consisted of one 12-week induction study (LUCENT-1) and one 40-week maintenance study (LUCENT-2) for 52 weeks of continuous treatment.
The research revealed that patients treated with mirikizumab achieved a greater reduction in rectal bleeding and stool frequency subscores as early as two weeks.
In addition, decreases in bowel urgency severity were observed as early as two weeks in patients treated with mirikizumab. After treatment, 42.9% of patients achieved bowel urgency remission at one year, compared to 25% of placebo.
Adverse reactions included upper respiratory tract infections, headache, rash and injection site reactions.
Mirikizumab has been recommended through the NICE cost-comparison process, meaning NHS England and commissioning groups have agreed to provide funding to implement this guidance within 30 days rather than the standard 90 days, providing faster access for patients.
Laura Steele, president and general manager, Northern Europe, at Eli Lilly, said: “The NICE recommendation establishes mirikizumab as the first IL-23p19 antagonist to be made available in the NHS for the treatment of adults with moderate to severe Ulcerative Colitis and reflects our commitment to immunological diseases with high unmet need. This is encouraging news for patients making Great Britain one of the first countries in the world to provide nationally reimbursed access; and national access should now be implemented within 30 days.”
Professor Jimmy Limdi, consultant gastroenterologist and head of the inflammatory bowel disease section at northern care alliance NHS foundation trust, 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 authorization and subsequent NICE recommendation of mirikizumab, the first IL- 23p19 inhibitor, is positive news for eligible people living with ulcerative colitis and I am delighted it will now be available on the NHS. It is a significant scientific advance welcomed by the medical community.”
