Lilly's Omvoh (mirikizumab-mrkz) meets primary endpoint of clinical remission and is the first IL-23p19 inhibitor to report one-year Phase 3 results in pediatric ulcerative colitis

Mark Genovese, Senior vice president of Lilly Immunology development

“For children and adolescents, the persistent bowel urgency, abdominal pain and unpredictability of ulcerative colitis can make a normal childhood feel out of reach, especially when symptoms return after previous treatments.”

Mark Genovese, Senior vice president of Lilly Immunology development

“Already approved for adults with ulcerative colitis, Omvoh is the first IL-23p19 inhibitor to report one-year Phase 3 results in pediatric ulcerative colitis.”

Mark Genovese, Senior vice president of Lilly Immunology development

“We look forward to working with regulators to potentially make Omvoh available to children and adolescents living with this disease, who continue to face substantial disease burden and ongoing unmet needs.”

Marla C. Dubinsky, Professor of Pediatrics and Medicine at the Icahn School of Medicine at Mount Sinai, Chief of Pediatric Gastroenterology and Nutrition at Mount Sinai Kravis Children’s Hospital

“For children with ulcerative colitis, every year spent relying on corticosteroids or facing the possibility of surgery can have important implications for growth, development and quality of life.”

Marla C. Dubinsky, Professor of Pediatrics and Medicine at the Icahn School of Medicine at Mount Sinai, Chief of Pediatric Gastroenterology and Nutrition at Mount Sinai Kravis Children’s Hospital

“Considering these challenges, the finding that half of the pediatric patients who responded to Omvoh achieved corticosteroid-free clinical remission without surgery at one year is particularly meaningful, especially in a population where many patients had previously experienced treatment failure with advanced therapies.”