Eli Lilly and Company (NYSE:LLY) witnessed a nearly 5% increase in its stock on Wednesday following an announcement by its competitor, Novo Nordisk (NYSE:NVO), regarding the success of a kidney outcomes study for its diabetes drug, Ozempic (semaglutide). The study was stopped earlier than originally planned due to its remarkable efficacy.
An independent data monitoring committee (DMC) recommended the early termination of the kidney outcomes study, known as FLOW, which assessed the once-weekly injectable Ozempic. The decision was based on an interim analysis that demonstrated the satisfaction of specific pre-defined criteria for terminating the study early in light of its effectiveness.
Ozempic, administered subcutaneously once a week, is currently approved in the United States in doses of 0.5 mg, 1.0 mg, and 2.0 mg for the treatment of type II diabetes. It is also approved for reducing the risk of major adverse cardiovascular events in adults with type II diabetes mellitus and established cardiovascular disease. Novo Nordisk’s FLOW study focuses on assessing Ozempic’s effectiveness in preventing the progression of renal impairment in individuals with type II diabetes and chronic kidney disease (CKD), as compared to a placebo.
Ozempic belongs to the class of GLP-1 receptor agonists. Eli Lilly also boasts a dual GIP and GLP-1 receptor agonist (GIP/GLP-1 RA) named Mounjaro (tirzepatide) in its product portfolio, which has already received approval for treating type II diabetes. Mounjaro is presently undergoing a phase II study to evaluate its efficacy for individuals who are overweight or obese and have CKD. Investors are anticipating a similarly positive outcome for Mounjaro’s CKD study.
Eli Lilly’s stock has experienced a significant surge, with a 65.4% year-to-date increase, in stark contrast to the industry’s 6.3% rise. The FDA granted approval to Mounjaro in 2022, and it has already begun to yield impressive sales figures, driven by robust demand. Sales of Mounjaro amounted to $1.55 billion in the first half of 2023. It is poised to become a major driver of Eli Lilly’s revenue in the long term, as it holds the potential for approval in the treatment of obesity and other diabetes-related conditions.
Mounjaro has demonstrated superior results in reducing weight in clinical trials for the treatment of obesity. Regulatory applications for Mounjaro’s use in obesity have already been submitted in the United States and the European Union. In the U.S., the FDA has granted priority review status to the regulatory filing, with a decision expected by the end of the year. Phase III studies are currently underway for obstructive sleep apnea and heart failure with preserved ejection fraction, while phase II trials are ongoing for non-alcoholic steatohepatitis (NASH).
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