The Medicines and Healthcare products Regulatory Agency (MHRA) has approved a new indication for the drug semaglutide (marketed as Wegovy by Novo Nordisk), allowing its use to reduce cardiovascular risks among overweight and obese adults with existing heart conditions or history of strokes.
This groundbreaking approval positions semaglutide as the first weight loss medication authorized to prevent significant cardiovascular events such as death, heart attack, and stroke in individuals with a Body Mass Index (BMI) of 27 kg/m2 or higher and established cardiovascular disease.
The decision follows compelling findings from a post-approval clinical trial published in the New England Journal of Medicine on November 11, 2023. The study showed that semaglutide (administered as a 2.4mg weekly subcutaneous injection) significantly reduced the occurrence of major adverse cardiovascular events by 20% compared to a placebo. The trial involved over 17,600 participants globally.
Paul Wright, a consultant pharmacist in cardiovascular disease at Barts Health NHS Trust, highlighted the significance of this approval, stating, “This is particularly vital for our local patient population and globally, as cardiovascular disease remains the leading cause of death. Semaglutide offers a promising intervention for a patient group that historically relies on a range of medications to manage associated health risks.
The US Food and Drug Administration (FDA) had previously approved Wegovy for a similar indication in March 2023, underscoring the potential of semaglutide to benefit cardiovascular health independently of weight loss.
The approval comes at a critical time when the availability of semaglutide is under pressure globally due to high demand and limited supply, exacerbated by off-label use and private prescribing. Rani Khatib, a consultant pharmacist at Leeds Teaching Hospitals NHS Trust, expressed concerns about the challenges in supply and access to weight management services necessary to administer the drug effectively.
As healthcare professionals and policymakers navigate these challenges, the approval of semaglutide for cardiovascular risk reduction marks a significant advancement in the treatment options available to combat obesity-related health issues.
