Lilly IBD biologic receives expanded US approval

The US Food and Drug Administration (FDA) has approved Omvoh ® (mirikizumab-mrkz) for moderately to severely active Crohn’s disease in US adults. The biologic was authorised in the US as a first-in-class therapy for adults with moderately to severely active ulcerative colitis in October 2023.

The agency’s expanded authorisation makes the treatment now approved in this market for two types of inflammatory bowel diseases (IBD).

Eli Lilly and Company shared that the treatment targets the interleukin-23p19 (IL-23p19) protein and inhibits the IL-23 pathway, consequently reducing inflammation within the GI tract.

Results from the biologic study

This approval is based on positive results from the Phase III VIVID-1 study of Omvoh in adults with moderately to severely active Crohn’s disease.

In VIVID-1, at one year, 53 percent of patients given Omvoh attained clinical remission. This was compared to 36 percent for participants in the placebo arm (which included patients who switched to treatment with Omvoh at 12 weeks).

Furthermore, over 80 percent of patients who achieved endoscopic response at one year maintained this response following an additional year of treatment (totalling two years of continuous treatment), the data showed.

Notably, nearly 90 percent of patients who achieved both clinical remission and endoscopic response at one year maintained their remission after two years of continuous treatment.

One year also marked 46 percent of patients given Omvoh achieving visible healing of the intestinal lining, compared to 23 percent for placebo.

An open-label extension study for Omvoh is ongoing in the VIVID-2 trial, evaluating the efficacy and safety of Omvoh for up to three years in adults with moderately to severely active Crohn’s disease, Eli Lilly noted.

Michael Osso, President and Chief Executive Officer, Crohn’s & Colitis Foundation, stated that the FDA’s expanded approval of gives adults with Crohn’s disease more treatment options.

“The FDA approval of Omvoh may help adults with Crohn’s disease achieve long-term remission and visible healing of the intestinal lining, even if they have tried other medications that did not work or stopped working,” explained Dr Marla Dubinsky, Chief, division of pediatric gastroenterology and nutrition, Co-Director, Susan and Leonard Feinstein IBD Clinical Center, Mount Sinai Kravis Children’s Hospital, Icahn School of Medicine, Mount Sinai New York.