BRIEF—MHRA nod for Lilly's UC therapy mirikizumab

US pharma major Eli Lilly has received Medicines and Healthcare products Regulatory Agency (MHRA) marketing authorization in Great Britain for mirikizumab, a ground-breaking therapy for ulcerative colitis (UC).

Mirikizumab is the first interleukin (IL)-23p19 targeted biologic to demonstrate efficacy for induction and maintenance therapy of moderately to severely active UC, says Lilly.

The marketing authorization was based on successful outcomes from the LUCENT-1 and LUCENT-2 Phase III trials, where mirikizumab achieved primary and key secondary endpoints, including sustained clinical remission.

Notably, in the LUCENT-1 trial, patients experienced significant decreases in bowel urgency severity as early as week 2 with mirikizumab compared to placebo.