FDA approves Omvoh for Crohn’s disease, expanding treatment options for inflammatory bowel disease
The U.S. Food and Drug Administration has approved Omvoh (mirikizumab-mrkz; Eli Lilly) for treating adults with moderately to severely active Crohn’s disease, expanding its use to a second major type of inflammatory bowel disease, according to a press release.
This approval is based on positive results from the Phase 3 VIVID-1 study, where Omvoh demonstrated significant improvements in clinical remission and endoscopic response at 1 year.
Omvoh, an interleukin-23p19 antagonist, was previously approved in the U.S. for treating moderately to severely active ulcerative colitis in adults.
“The burden of Crohn’s disease on patients’ daily lives is substantial,” said Michael Osso, president and chief executive officer, Crohn’s & Colitis Foundation in the press release. “This approval is meaningful for adult patients with Crohn’s disease, who now have more treatment options available.”
Read the full press release here.