FDA Approves First Treatment to Reduce Risk of Serious Heart Problems Specifically in Adults with Obesity or Overweight
On 8 March, the U.S. Food and Drug Administration approved a new indication for use for Wegovy (semaglutide) injection to reduce the risk of cardiovascular death, heart attack and stroke in adults with cardiovascular disease and either obesity or overweight.
The FDA decision is based on the results of the landmark SELECT phase III cardiovascular outcomes trial that examined the effect of adding Wegovy® 2.4 mg or placebo to cardiovascular standard of care in adults with overweight and obesity with established CVD and without diabetes. Wegovy® 2.4 mg significantly reduced the risk for first occurrence of a three-part composite MACE endpoint consisting of cardiovascular death, non-fatal heart attack, or non-fatal stroke. The primary composite outcome occurred in 6.5% of patients treated with Wegovy® and 8.0% with placebo. The estimated relative risk reduction of MACE was 20% vs placebo (HR 0.80 [95% CI: 0.72, 0.90] p <0.001, absolute risk reduction of 1.5% at 40 months, the mean follow-up duration).The reduction of MACE with Wegovy® was not impacted by age, sex, race, ethnicity, baseline BMI, or level of renal function impairment.
"This approval is a significant decision because people living with excess weight or obesity and established cardiovascular disease and without diabetes have never had an FDA-approved treatment option that lowers weight and reduces the likelihood of another cardiovascular event," said Dr. A. Michael Lincoff, Professor of Medicine at Cleveland Clinic and the lead study author of the SELECT outcomes trial. "For healthcare professionals, this approval provides a new treatment option to help us address cardiovascular residual risk that remains for patients on current standard of care."
Sources:
News details (novonordisk-us.com)
