Semaglutide new indication to reflect risk reduction of MACE has been approved by the European Medicines Agency
On July 25, 2024, the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) had adopted a positive opinion. They agreed to update the label of Wegovy (2.4 mg semaglutide) to reflect data from the SELECT cardiovascular outcome trial. 2.4 mg semaglutide is used for weight loss. This trial proves that Wegovy can reduce the risk of major adverse cardiovascular events (MACE). It including cardiovascular death, non fatal heart attack (myocardial infarction) or non fatal stroke, in adults diagnosed with cardiovascular disease and overweight or obese (initial body mass index [BMI] ≥ 27 kg/m2) without diabetes.
SELECT is a randomized double-blind, parallel group, placebo-controlled trial. It aimed at evaluating the efficacy of 2.4 mg Wegovy as an adjuvant therapy in preventing MACE compared to placebo. The trial recruited about 17000 overweight or obese adult patients aged 45 years or above who were diagnosed with cardiovascular disease and had no previous history of diabetes.
The SELECT trial showed semaglutide significantly reduced the risk of MACE in patients by 20%. The risk of MACE is reduced regardless of baseline age, gender, race, ethnicity, BMI value, and degree of renal impairment. The exact mechanism of cardiovascular risk reduction is not yet determined, but it may involve many factors.
This label update also includes other results from the SELECT experiment. Data shows that compared to placebo, Semaglutide can reduce the risk of cardiovascular death in patients by 15%. Reduce the risk of death from any cause by 19%. The risk of heart failure composite events (including cardiovascular death, emergency heart failure visits, and heart failure hospitalizations) also reduce by 18%.
In terms of safety, Wegovy has demonstrated good safety and tolerability characteristics consistent with previous trials.
