EMA Panel Endorses Lilly's Omvoh for Expanded Use in Crohn's Disease

Company Overview - Eli Lilly (LLY) announced that the EMA's Committee for Medicinal Products for Human Use (CHMP) recommended approving its IL-23p19 antibody Omvoh (mirikizumab) for expanded use in Crohn's disease (CD) [1] - Omvoh is currently approved in more than 44 countries, including the United States and Europe, to treat adults with moderate-to-severely active ulcerative colitis (UC) [3] Clinical Data and Regulatory Status - The positive recommendation for Omvoh is based on data from the phase III VIVID-1 study, which demonstrated effectiveness in CD patients with or without prior biologic failure [2] - A similar regulatory filing for Omvoh is under review with the FDA, with a final decision expected in the first half of 2025 [2] Market Performance - Year to date, Eli Lilly's shares have risen 35.4% compared to the industry's growth of 6.3% [4] Competitive Landscape - The targeted inflammatory bowel disease (IBD) market is highly competitive, with key players including AbbVie (ABBV) and Johnson & Johnson (JNJ) [6][7] - AbbVie's key immunology products, Skyrizi and Rinvoq, have generated nearly $10 billion in combined sales in the first nine months of 2024 [8] - J&J's Stelara and Tremfya have also performed well, with Stelara contributing over $8 billion in sales and Tremfya recording $2.7 billion in the same period [10][11] Industry Trends - There has been a surge in the prevalence of IBD disorders due to genetic, environmental, and lifestyle factors, driving demand for treatments [6] - Several major drugmakers, including Merck, Pfizer, Novartis, Sanofi, Gilead, and Amgen, are developing new medicines with novel mechanisms of action for IBD [12]