INDIANAPOLIS - Eli Lilly and Company (NYSE: NYSE:LLY), a pharmaceutical giant with a market capitalization of $672 billion and impressive revenue growth of 27% in the past year, has received U.S. Food and Drug Administration (FDA) approval for Omvoh (mirikizumab-mrkz) to treat adults with moderately to severely active Crohn's disease. This approval follows the drug's previous sanction for ulcerative colitis in October 2023. According to InvestingPro analysis, Eli Lilly maintains an exceptional gross profit margin of 81%, highlighting its operational efficiency in bringing new drugs to market.
Omvoh, which targets the interleukin-23p19 (IL-23p19) protein, is the first biologic therapy to reveal two-year Phase 3 efficacy data for Crohn's disease at the time of approval. The drug is designed to reduce inflammation in the gastrointestinal tract, a significant aspect of Crohn's disease pathology.
The FDA's decision is based on results from the Phase 3 VIVID-1 trial, where Omvoh demonstrated effectiveness in achieving clinical remission and endoscopic response after one year of treatment in patients who had not responded to other therapies. In the trial, 53% of Omvoh-treated patients reached clinical remission, and 46% showed endoscopic response, compared to 36% and 23%, respectively, for those on placebo. As a prominent player in the pharmaceuticals industry, Eli Lilly continues to strengthen its market position, with analysts maintaining a strong buy consensus and projecting significant earnings growth. For detailed financial analysis and 14 additional key insights about Eli Lilly, visit InvestingPro.
Furthermore, the VIVID-2 open-label extension study indicates that nearly 90% of patients who achieved clinical remission and endoscopic response after one year maintained remission with two years of continuous Omvoh treatment.
The overall safety profile of Omvoh in Crohn's disease patients was generally consistent with that observed in ulcerative colitis patients. Common adverse reactions included upper respiratory tract infections, injection site reactions, headache, arthralgia, and elevated liver tests.
Eli Lilly has also filed marketing applications for Omvoh in Crohn's disease in the European Union and Japan, with additional global submissions planned. Omvoh is already approved for ulcerative colitis in 44 countries.
The company is working with insurers and health systems to ensure access to Omvoh, and patient support programs, including co-pay assistance, are available for eligible patients.
This article is based on a press release statement from Eli Lilly and Company. While the company's stock currently trades above its InvestingPro Fair Value, its strong financial health score and robust cash flows suggest continued growth potential. Access comprehensive valuation metrics and the detailed Pro Research Report covering Eli Lilly's business outlook through InvestingPro.
In other recent news, pharmaceutical giant Eli Lilly has experienced several significant developments. The company's Q4 revenue of $13.5 billion fell short of the consensus estimate of around $14 billion, attributed to weaker-than-expected sales from its Mounjaro and Zepbound portfolio. Despite this, analysts from Bernstein, BMO Capital, Wells Fargo (NYSE:WFC), BofA Securities, and Citi maintain positive ratings on Eli Lilly, with price targets ranging from $997 to $1,250.
Eli Lilly has also recently acquired Scorpion Therapeutics' PI3Kα inhibitor program in a deal that could total $2.5 billion. Furthermore, the company provided revenue guidance for 2025, projecting total revenues between $58 and $61 billion, reflecting a positive growth outlook. Analysts from BofA Securities and Citi maintain a Buy rating on Eli Lilly, emphasizing the potential of the company's oral GLP-1 treatment candidate, Orforglipron, expected to launch in early 2026.
Despite preliminary Q4 revenue falling short of expectations, Eli Lilly projects a 32% revenue growth for 2024 and guides higher for 2025. Analysts from Truist Securities reaffirmed their Buy rating on Eli Lilly, expressing confidence in the company's obesity drugs, Mounjaro and Zepbound. These are the recent developments for Eli Lilly.
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