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.
Pykus Therapeutics' PYK-2101 achieves positive interim clinical trial results
FDA accepts Novo Nordisk's filing application for oral semaglutide 25 mg
Nutshell Therapeutics' NTS071 p53 allosteric reactivator cleared for US clinical trial
Blue Earth Therapeutics initiates Phase 2 trial in metastatic castrate resistant prostate cancer
Armata Pharmaceuticals' AP-SA02 clinical trial receives additional US DoD funding
BioArctic receives SEK101.7m in royalties from Q1 Leqembi sales
SKNV launches Kefunova Cream for actinic keratosis and superficial basal cell carcinoma
Ingenium Therapeutics' Gengleucel to enter Phase 2 trial in MRD+ AML following FDA feedback
Nuformix receives positive EMA opinion for orphan drug designation of NXP002 in IPF
MHRA to review monthly maintenance dosing for Leqembi in early Alzheimer's treatment
Ro integrates with NovoCare Pharmacy to offer access to all doses of Wegovy at lowest price
Myosin Therapeutics receives grant to advance MT-110 clinical trial in methamphetamine use disorder
CSL Vifor and Travere Therapeutics gain full EU approval for FILSPARI in IgA nephropathy