Novo Nordisk (NYSE: NVO)’s anti-obesity drug Wegovy (semaglutide) has received a new indication approval in the United Kingdom, with the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) granting approval for its use in reducing the risk of serious heart problems or strokes in overweight or obese adults. This marks Wegovy as the first weight loss drug to be recognized for its ability to reduce cardiovascular disease (CVD)-related deaths. The approval is specifically for the 2.4mg dosage of Wegovy and is limited to individuals with established CVD and a Body Mass Index (BMI) of 27 kg/m2 or higher.
Following a similar approval by the US FDA in March this year, the UK’s decision comes ahead of the European Medicines Agency (EMA), which is still reviewing Novo Nordisk’s supplementary filing. Wegovy’s cardiovascular benefits were demonstrated in the SELECT clinical trial, which included over 17,500 patients and showed a 20% reduction in the risk of major adverse cardiovascular events (MACE), such as cardiovascular death, heart attack, or stroke, with 6.5% of Wegovy-treated participants experiencing these events compared to 8% of those on placebo .- Flcube.com
