US pharmaceutical company Eli Lilly and Company (NYSE:LLY) announced on Wednesday that it has received approval from the US Food and Drug Administration (FDA) for Omvoh (mirikizumab-mrkz) for the treatment of moderately to severely active Crohn's disease in adults.
Omvoh is now approved in the United States for two types of inflammatory bowel disease (IBD), following its October 2023 approval as a first-in-class treatment for moderately to severely active ulcerative colitis (UC) in adults. 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. Lilly says that 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 FDA decision was 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).
Adicet Bio secures FDA Fast Track Designation for ADI-001 to treat refractory SLE
Acrivon Therapeutics receives FDA Breakthrough Device designation for ACR-368 OncoSignature assay
Vistagen secures US patent for AV-101 in neuropathic pain treatment
Thermo Fisher Scientific launches international registry for adolescent alopecia areata
hVIVO successfully completes RSV antiviral trial for Shionogi
Valneva secures UK approval for world's first chikungunya vaccine
Alys Pharmaceuticals' IND for ALY-101 approved in US and Canada
NeuroTherapia's Phase 2 Alzheimer's disease trial receives European regulatory approval
NFL Biosciences confirms superior safety profile of NFL-101 in new toxicity study
Avirmax Biopharma completes first cohort of Wet AMD clinical trial
PhaseV collaborates with Alimentiv to address challenges in GI clinical trials
HOPE Therapeutics and NRx Pharmaceuticals select BTIG as financial advisor
Helix unveils clinico-genomic dataset of over 15,000 patients treated with GLP-1 agonists
Roquefort Therapeutics sells Lyramid for USD10.8m equity deal with Pleiades Pharma