INDIANAPOLIS - Eli Lilly and Company (NYSE:LLY), a pharmaceutical giant with a market capitalization of $705 billion and impressive gross profit margins of 81%, announced today that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended approval of Omvoh (mirikizumab) for the treatment of adults with moderately to severely active Crohn's disease who have not responded adequately to conventional or biologic therapies. According to InvestingPro analysis, Lilly is currently trading above its Fair Value, reflecting strong investor confidence in its pipeline developments. This positive opinion brings Omvoh closer to becoming the first Crohn's disease treatment to include improvements in histologic measures of inflammation on its label, if approved by the European Commission.
The CHMP's endorsement is based on the Phase 3 VIVID-1 trial, which demonstrated that patients treated with mirikizumab experienced significant improvements in clinical remission and endoscopic response, as well as all major secondary endpoints, at both Week 12 and Week 52 compared to placebo. Notably, Omvoh was also the first pivotal Crohn's disease trial to report benefits in the challenging symptom of bowel urgency, using a patient-centric scale.
Dr. Stefan Schreiber, director of the Clinic for Internal Medicine I at Kiel Campus of the University Hospital Schleswig-Holstein, expressed enthusiasm for Omvoh's potential to provide comprehensive disease control, including relief from disruptive symptoms and control of intestinal inflammation.
The safety profile of mirikizumab in patients with Crohn's disease was consistent with its known safety profile in ulcerative colitis (UC), for which Omvoh was previously approved in 2023 in the European Union, U.S., Japan, and 44 countries worldwide.
The European Commission's final decision on the approval of Omvoh for Crohn's disease is anticipated within the next one to two months. Lilly has also submitted marketing applications for Omvoh in Crohn's disease in the U.S. and Japan, with regulatory decisions expected in the first half of 2025. With revenue growth of 27% in the last twelve months and strong analyst support, Lilly continues to demonstrate robust market performance. InvestingPro subscribers can access 15+ additional exclusive insights about Lilly's financial health and growth prospects through the comprehensive Pro Research Report.
Crohn's disease is a chronic inflammatory bowel disease that can lead to progressive bowel damage, disability, and reduced quality of life. Current treatments do not provide remission for the majority of patients or maintain it long term. Omvoh's approval would represent a significant advancement in the treatment options available for this patient population. With an impressive financial health score rated as "GOOD" by InvestingPro analysts and a strong track record of dividend payments for 54 consecutive years, Lilly demonstrates the financial stability needed to support its innovative drug development programs. Unlock detailed valuation metrics, growth forecasts, and expert analysis with an InvestingPro subscription.
This news is based on a press release statement issued by Eli Lilly and Company.
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