Pharmaceutical company Eli Lilly and Company (NYSE:LLY) on Friday announced new data from the VIVID-2 open-label extension study demonstrating that most patients with moderately to severely active Crohn's disease receiving Omvoh (mirikizumab-mrkz) maintained long-term clinical remission and endoscopic response over two years.
Among patients in clinical remission at one year, 92.9% sustained remission at two years, while 87.6% maintained an endoscopic response.
Omvoh is the first IL-23p19 antagonist to demonstrate sustained multi-year efficacy and safety for Crohn's disease and ulcerative colitis. The study included patients with prior biologic failure, with 43.8% of participants having previously not responded to biologic therapies.
The safety profile of Omvoh in VIVID-2 was consistent with prior studies, with 6.8% of patients reporting a serious adverse event in the second year and 0.8% discontinuing treatment due to adverse events. Additional trials are ongoing to assess long-term efficacy and safety in paediatric and adult patients.
Omvoh received US Food and Drug Administration (FDA) approval for Crohn's disease in January 2025, and a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use in December 2024. Lilly has submitted global marketing applications, including in Canada, Japan and China.
Johnson & Johnson's nipocalimab granted FTD for treatment of Sjogren's disease
RedHill Biopharma to submit Talicia for UK marketing authorisation
bioMérieux receives FDA clearance for VITEK COMPACT PRO to combat antimicrobial resistance
GRIN Therapeutics' Radiprodil receives Orphan Drug designation
BioArctic receives US FDA orphan drug designation OOPD for exidavnemab
Eneboparatide Shows Positive Results in Phase III Trial for Chronic Hypoparathyroidism
Precision BioSciences secures IND clearance for gene editing therapy targeting chronic hepatitis B
Xeris Biopharma secures FDA approval for Gvoke VialDx as diagnostic aid
AstraZeneca secures EU approval for Imfinzi in limited-stage small cell lung cancer
ANI Pharmaceuticals secures FDA approval for ILUVIEN label expansion
Korro Bio receives FDA orphan drug designation for KRRO-110
SpliceBio doses first patient in Phase 1/2 ASTRA study of SB-007
Amgen reports positive Phase 3 trial results for UPLIZNA in generalised myasthenia gravis
Femasys receives CE mark approval for FemBloc delivery system in Europe
European Commission approves Rxulti for adolescent schizophrenia treatment