NICE recommends mirikizumab for Crohn’s disease treatment

New guidance expands treatment options for eligible patients

The National Institute for Health and Care Excellence (NICE) has issued final draft guidance recommending mirikizumab (Omvoh) for adults with moderately to severely active Crohn’s disease who have not responded to previous biological treatment or cannot tolerate it.

The decision comes less than two months after the Medicines and Healthcare products Regulatory Agency granted marketing authorisation for mirikizumab in the UK. It will be available to eligible patients in England within 30 days of publication of the final guidance and within 60 days in Wales.

Mirikizumab demonstrated positive outcomes in the phase 3 VIVID-1 trial, with 45% of treated patients achieving clinical remission at one year, compared to 20% on placebo. Additionally, 38% of treated patients had visible healing of the intestinal lining at one year, compared to 9% on placebo.

James Lindsay, professor of inflammatory bowel disease at Barts and the London School of Medicine and Dentistry, Queen Mary University of London, and consultant gastroenterologist at Barts Health NHS Trust, said: “Many patients with Crohn’s disease have explored several of the currently available therapies but are still seeking a treatment option that effectively helps manage their symptoms.”

Marianne Radcliffe, CEO of Crohn’s & Colitis UK, said: “Crohn’s disease is a lifelong condition affecting more than 200,000 people in the UK. Expanding the treatment options for eligible people living with Crohn’s – with drugs like mirikizumab – can only be a good thing!”

Mirikizumab’s safety profile is generally consistent with its known effects in ulcerative colitis, with common adverse reactions including headache, upper respiratory tract infection and joint pain.