Brazil's Anvisa approved on Monday, February 2, 2026, the expansion of therapeutic indications for semaglutide, the active ingredient in Wegovy and Ozempic. Wegovy can now be used to reduce the risk of heart attacks and strokes in adults with cardiovascular disease and overweight, while Ozempic is indicated for type 2 diabetes associated with chronic kidney disease. The agency is also reviewing a request for an oral version of Wegovy.
Brazil's National Health Surveillance Agency (Anvisa) announced on February 2, 2026, the expansion of indications for semaglutide, the active ingredient in Wegovy and Ozempic, produced by Novo Nordisk. Previously limited to obesity treatment, Wegovy is now authorized to reduce the risk of major cardiovascular events, such as heart attacks and strokes (AVC), in adults with established cardiovascular disease and obesity or overweight. This decision is based on studies showing significant reductions in these events when the drug is combined with a low-calorie diet and increased physical activity. In Brazil, around 400,000 deaths per year are caused by heart attacks or strokes.
For Ozempic, the approval extends its use to treating type 2 diabetes mellitus associated with chronic kidney disease. Data from the Brazilian Society of Nephrology in 2024 show that 29% of dialysis patients in the country are diabetic. The study presented by the manufacturer demonstrates that the drug, along with standard therapy, slows the progression of kidney failure and reduces deaths from major adverse cardiovascular events.
Cardiologist Silvio Giopato from the University of Campinas Clinical Hospital highlighted the potential for long-term reduction in heart attack incidence but warned about the high cost of the medications, ranging from R$ 825 to R$ 1,799 depending on dosage, and their unavailability in the public health system (SUS). "It's important to remember that although positive signals start in two to three years, full benefits only occur with continuous use of the medication. Clearly, the economic aspect weighs heavily, making the therapy inaccessible to most of the population," Giopato said.
Additionally, Novo Nordisk filed on January 30 for registration of an oral version of Wegovy, in 25 mg semaglutide tablets. If approved, it would be the first oral GLP-1 agonist for weight management. Clinical studies indicate an average weight loss of 16.6% of body weight, similar to the injectable version, with one-third of participants losing 20% or more. Rybelsus, another semaglutide-based product, is already sold in Brazil but only for type 2 diabetes.
