The pill form of Ozempic could help reduce the risk of heart attacks, study says
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The pill version of Novo Nordisk’s (NVO-0.46%) blockbuster drug Ozempic was found to cut the risk of heart attacks, strokes, and other cardiovascular events in a late-stage clinical trial.
The Danish pharma giant announced Monday that the oral form of semaglutide, the active ingredient in Ozempic and Wegovy, was shown to reduce the risk of major adverse heart events by 14% among people with Type 2 diabetes and cardiovascular disease and/or chronic kidney disease, compared with patients who were given a placebo. Oral semaglutide is branded as Rybelsus in the United States and is currently approved for treating Type 2 diabetes.
The company’s Phase 3 “SOUL” trial had nearly 10,000 patients enrolled and assessed the effect of oral semaglutide on heart health outcomes over three years.
“We are pleased to see that the results from SOUL demonstrate that oral semaglutide reduces the risk of cardiovascular events and that the benefits of oral semaglutide come on top of standard of care,” said Martin Holst Lange, executive vice president of development at Novo Nordisk, in a press release. “Approximately one in three adults with type 2 diabetes also have cardiovascular disease; therefore, it is crucial to have therapies that can address both conditions.”
Novo Nordisk said it plans to ask the Food and Drug Administration (FDA) to expand the approved use of Rybelsus to include reducing the risk of adverse heart events.
The news comes as both Novo Nordisk and its rival Eli Lilly (LLY-0.49%) are working to get more approved uses of their GLP-1 treatments beyond diabetes and weight loss. These additional approvals make it easier for health insurers to cover the medications.
GLP-1s are a popular class of diabetes and obesity medications that mimic a hormone that regulates blood sugar and reduces appetite. Demand for these medications has turned Novo Nordisk and Eli Lilly, the producer of Mounjaro and Zepbound (both GLP-1 drugs for diabetes and weight loss), into the largest pharma companies in the world.
In March, the FDA expanded the approved use of Novo Nordisk’s Wegovy, months after the company announced results from a clinical trial that found the drug cut the risk of serious heart events by 20%. This opened the path for the weight loss drug to get coverage from Medicare.
Earlier this year, Eli Lilly announced results from clinical trials that found tirzepatide, the drug behind Mounjaro and Zepbound, helped with sleep apnea and heart failure.
