Eli Lilly’s Omvoh (mirikizumab) has been recommended by the National Institute for Health and Care Excellence (NICE) to treat moderately to severely active Crohn’s disease in adults on the NHS in England and Wales.
The health technology assessment agency has recommended in final draft guidance that the drug be used in patients whose disease has not responded well enough or stopped responding to a previous biological treatment, not tolerated a previous biological treatment, or been unsuitable for tumour necrosis factor-alpha inhibitors.
NICE’s decision comes less than two months after the Medicines and Healthcare products Regulatory Agency approved Omvoh for use in the UK and was based on positive data from the late-stage VIVID-1 study.
Results showed that 45% of Omvoh-treated patients achieved clinical remission at one year, compared to 20% of those receiving placebo.
Visible healing of the intestinal lining at one year was seen in 38% of patients receiving Lilly’s drug versus 9% on placebo. Additionally, 33% of patients in the Omvoh cohort achieved early improvement in endoscopic response, compared to 13% in the placebo group at three months.
Crohn’s disease is one of the two main types of inflammatory bowel disease (IBD), which affects more than 500,000 people in the UK.
The condition causes symptoms such as persistent diarrhoea and abdominal pain and, if not adequately controlled, can lead to complications that require hospitalisation and surgical intervention.
Lilly’s Omvoh is already recommended by NICE to treat certain cases of ulcerative colitis, another of the two main forms of IBD, and is designed to reduce inflammation within the gastrointestinal tract by targeting the interleukin-23p19 protein.
James Neville, associate vice president of specialty care, Lilly UK and Ireland, said: “People living with Crohn’s disease have shared with us how truly disruptive symptoms such as abdominal pain, frequent bowel movements and bowel urgency can be.
“With [Omvoh] now authorised in both Crohn’s disease and ulcerative colitis, more patients will have access to a treatment option that may provide long-term disease control and address key symptoms that matter most to them…”