Eli Lilly’s Omvoh (mirikizumab) has been recommended by the European Medicines Agency’s human medicines committee to treat Crohn’s disease.
The Committee for Medicinal Products for Human Use (CHMP) has recommended that the drug be used to treat adults with moderately to severely active cases of the disease who have had an inadequate response with, lost response to, or been intolerant to either conventional therapy or a biologic treatment.
Crohn’s disease is an inflammatory bowel disease (IBD) that causes symptoms such as persistent diarrhoea and abdominal pain and, if not adequately controlled, can lead to complications that require hospitalisation and surgical intervention.
Already approved in the EU to treat moderately to severely active cases of ulcerative colitis, another form of IBD, Lilly’s Omvoh is designed to block the action of interleukin-23 to reduce the inflammation and symptoms associated with the disease.
The CHMP’s decision was supported by positive results from the late-stage VIVID-1 study, which compared the safety and efficacy of Omvoh against placebo or ustekinumab.
Omvoh-treated patients achieved statistically significant improvements on both co-primary endpoints, composite endoscopic response and composite clinical remission, as well as all major secondary endpoints compared to those receiving placebo at weeks 12 and 52.
Improvements in bowel urgency severity were also achieved with Omvoh, as measured by an 11-point scale developed by Lilly, and the drug’s overall safety profile was consistent with its known safety profile in patients with ulcerative colitis.
The European Commission will now consider the CHMP’s recommendation as it makes its decision on Omvoh in this indication.
Mark Genovese, senior vice president of Lilly immunology development, said: “Disruptive symptoms of Crohn’s disease, such as bowel urgency, can interfere with all aspects of life, leaving many people searching for treatments that can help them fully participate in the things that they enjoy.
“Given the efficacy we saw on clinical remission and endoscopic response, combined with the improvements in bowel urgency and histological inflammation, this positive CHMP opinion for Omvoh brings us a step closer to advancing care for more people with IBD around the world.”