Eli Lilly and Company (Lilly) has received the US Food and Drug Administration (FDA) approval for Omvoh (mirikizumab-mrkz) to treat adults with moderately to severely active Crohn’s disease.
Omvoh is an interleukin-23p19 antagonist that selectively targets the p19 subunit of IL-23 and inhibits the IL-23 pathway, which plays a key role in inflammatory bowel disease (IBD).
The drug is already approved in the US in October last year for the treatment of moderately to severely active ulcerative colitis (UC) in adults.
Currently, Omvoh is approved in the US for two types of inflammatory bowel disease (IBD).
Omvoh comes with labelled warnings and precautions related to hypersensitivity reactions, risk of infection, tuberculosis, hepatotoxicity and immunisations.
Lilly Research Laboratories and Lilly Immunology president, chief scientific officer Daniel Skovronsky 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 approved in both Crohn’s disease and ulcerative colitis, more patients now have a treatment option that may provide long-term disease control and address key symptoms that matter most to them, reflecting Lilly’s ongoing commitment to elevate care and improve outcomes for patients.”
The FDA approval is based on positive results from the Phase 3 VIVID-1 study of Omvoh in adults with moderately to severely active Crohn’s disease who were previously treated.
The Phase 3 study met both primary endpoints, including clinical remission by Crohn’s Disease Activity Index (CDAI) and endoscopic response at one year.
Also, 53% of patients treated with Omvoh achieved clinical remission at one year, and 46% of patients had visible healing of the intestinal lining, with Omvoh.
In addition, 32% of Omvoh patients achieved early improvement in endoscopic response, defined by visible healing of the intestinal lining, versus 11% on placebo at three months.
Omvoh is also being evaluated in VIVID-2, an ongoing, open-label extension (OLE) study of the efficacy and safety of Omvoh for up to three years in adults with active Crohn’s disease.
In both VIVID-1 and VIVID-2, Omvoh’s overall safety profile in patients with moderately to severely active Crohn’s disease was generally consistent with its known safety profile.
The most common adverse reactions include upper respiratory tract infections, injection site reactions, headache, arthralgia, and elevated liver tests.
Furthermore, Lilly has submitted marketing applications for Omvoh in Crohn’s disease around the world, including in the European Union (EU) and Japan.
Crohn’s & Colitis Foundation president and CEO Michael Osso said: “The burden of Crohn’s disease on patients’ daily lives is substantial. This approval is meaningful for adult patients with Crohn’s disease, who now have more treatment options available.”
