USFDA approves Eli Lilly Omvoh for Crohn's disease

Omvoh works to reduce inflammation within the gastrointestinal tract by targeting a specific protein, interleukin-23p19 (IL-23p19), which is a key contributor to intestinal inflammation. "Omvoh is the first biologic treatment in more than 15 years to have disclosed two-year Phase 3 efficacy data in Crohn's disease at the time of approval," the Company stated in a BSE filing.

"The burden of Crohn's disease on patients' daily lives is substantial," said Michael Osso, president and chief executive officer, Crohn's & Colitis Foundation. "This approval is meaningful for adult patients with Crohn's disease, who now have more treatment options available."

This 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 had an inadequate response, loss of response, or intolerance to corticosteroids, immunomodulators (azathioprine, 6-mercaptopurine and methotrexate) and/or biologics (TNF blockers, integrin receptor antagonists). VIVID-1 was a randomized placebo-controlled trial of Omvoh. Patients randomized to placebo who did not achieve clinical response by patient-reported outcome at 12 weeks (40% of placebo patients) were subsequently switched to Omvoh treatment. Both primary endpoints in VIVID-1 were achieved:

• Clinical remission by Crohn's Disease Activity Index (CDAI) at one year
  • 53% of patients treated with Omvoh achieved clinical remission at one year versus 36% on placebo (p<0.001).
• Endoscopic response at one year
  • 46% of patients treated with Omvoh had visible healing of the intestinal lining at one year versus 23% on placebo* (p<0.001).

Additionally, 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 (p<0.001).

Omvoh is also being studied in VIVID-2, an ongoing, open-label extension (OLE) study evaluating the efficacy and safety of Omvoh for up to three years in adults with moderately to severely active Crohn's disease. Among patients who achieved endoscopic response at one year in VIVID-1, over 80% maintained endoscopic response with one year of additional treatment (two years of continuous treatment). Additionally, among patients who achieved clinical remission and endoscopic response at one year in VIVID-1, nearly 90% of patients maintained clinical remission with one year of additional treatment (two years of continuous treatment).

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 in patients with UC. The labeling for Omvoh contains warnings and precautions related to hypersensitivity reactions, risk of infection, tuberculosis, hepatotoxicity and immunizations.

"Many patients with Crohn's disease have tried available therapies and are still seeking a treatment option that can work well for them to help control their disease," said Marla Dubinsky, M.D., 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. "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."

Lilly has also submitted marketing applications for Omvoh in Crohn's disease around the globe, including in the European Union and Japan. Additional global regulatory submissions are planned. In UC, Omvoh is currently approved in 44 countries.

"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," said Daniel M. Skovronsky, M.D., Ph.D., chief scientific officer, and president of Lilly Research Laboratories and Lilly Immunology. "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."