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Anvisa Expands Wegovy and Ozempic Uses to Cardiovascular and Kidney Protection

Regulators cited trial evidence that semaglutide reduces major cardiac events independent of weight loss.

Overview

  • Brazil’s health regulator approved Wegovy to lower the risk of heart attack and stroke in adults with established cardiovascular disease who also have obesity or overweight.
  • Ozempic’s label now includes treatment for people with type 2 diabetes and chronic kidney disease, with studies showing slower kidney decline and fewer cardiovascular deaths when added to standard care.
  • Novo Nordisk filed for Anvisa approval of a 25 mg oral Wegovy on January 30 after a late‑December FDA clearance, reporting average weight loss around 16.6% to 17% and a safety profile similar to the injectable with mostly mild gastrointestinal effects.
  • A Lancet‑published analysis from the SELECT trial found semaglutide’s cardiovascular protection was not fully explained by the amount of weight lost.
  • Novo Nordisk reported phase 3 REIMAGINE results showing its combination injection CagriSema produced greater weight loss than Wegovy in trials, including 14.2% versus 10.2% after 68 weeks in adults with type 2 diabetes.