finance.yahoo.com
FDA Approves Expanded Use Of Eli Lilly's Ulcerative Colitis Drug For Crohn's Disease
A new FDA approval expands treatment options for adults with moderate-to-severe Crohn's disease and means mirikizumab (Omvoh) is now approved for both Crohn's disease and ulcerative colitis. The decision was based on Phase 3 trial results showing clinical and endoscopic benefit at one year.
Adults with moderate-to-severe Crohn's disease, patients considering or on biologic therapy, gastroenterologists and IBD clinicians, and researchers tracking IL-23–targeted treatments.
What To Know
The FDA has approved Eli Lilly's Omvoh (mirikizumab-mrkz / mirikizumab) for moderately to severely active Crohn's disease in adults, expanding its prior U.S. approval for ulcerative colitis.
The approval is based on Phase 3 VIVID-1 results reporting clinical remission and endoscopic response at one year versus placebo, and longer-term maintenance data are being collected in an open-label extension (VIVID-2). Omvoh is an IL-23p19–targeting biologic (mirikizumab) now approved for two types of IBD in adults.
The VIVID-1 trial met its primary endpoints for clinical remission (CDAI) and endoscopic response at one year, and some patients showed maintained responses with continued treatment up to two years in extension data.
The article summarizes headline trial outcomes from the company/press report rather than presenting full trial publications or guideline changes.
If you’re reading this because you or someone you care for has IBD: this approval means another biologic option is now available for adults with moderate-to-severe Crohn’s disease, particularly for people and clinicians considering IL-23–targeted therapy.
Talk with your care team about whether this medicine is appropriate given your treatment history and insurance coverage.
This is a regulatory approval reported in a news article summarizing Phase 3 trial outcomes (VIVID-1) and extension data (VIVID-2). The piece is a press/finance news report rather than a detailed clinical paper or guideline update. Individual treatment decisions should be made with a clinician; approvals do not automatically change recommended care for every patient.
