MHRA Approves Novo Nordisk's Semaglutide for Cardiovascular Risk Reduction

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted a new indication for Novo Nordisk's semaglutide, marketed under the name Wegovy, aimed at reducing the risk of severe heart issues in adults who are overweight or obese. This decision expands the medication's use beyond its prior approval for obesity management and weight loss, which was to be used in conjunction with dietary and lifestyle changes.

Semaglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist, is now the first medication for weight loss also proven to avert cardiovascular incidents, such as heart attacks and strokes, particularly in individuals with a body mass index (BMI) of 27 kg/m² or higher who already suffer from established cardiovascular disease.

The recent approval was based on evidence from a comprehensive post-approval clinical study. This study highlighted that administering 2.4mg of semaglutide weekly through subcutaneous injections over a period of up to five years led to a significant reduction in major adverse cardiovascular events (MACE) compared to a placebo. This multi-national, multicentre, placebo-controlled, double-blind trial included 17,600 participants and demonstrated that those who received Wegovy had a 20% lower risk of experiencing MACE.

Semaglutide functions by mimicking the GLP-1 hormone, which plays a crucial role in regulating blood sugar levels. The medication binds to GLP-1 receptors in the pancreas, enhancing insulin secretion after meals, reducing glucagon release, and slowing gastric emptying, all of which contribute to weight loss.

However, gastrointestinal side effects such as nausea and vomiting are commonly associated with semaglutide. The MHRA will continue to monitor the safety and effectiveness of the medication, urging individuals who experience side effects to seek medical advice and report any concerns through the MHRA Yellow Card scheme.

Shirley Hopper, Deputy Director of Innovative Medicines at the MHRA, emphasized the agency's commitment to ensuring access to high-quality, safe, and effective medical products. She remarked, “Our key priority is enabling access to high-quality, safe, and effective medical products. We’re assured that the appropriate regulatory standards of safety, quality, and effectiveness for the approval of this medicine have been met. This treatment option that prevents heart disease and strokes is an important step forward in tackling the serious health consequences of obesity.”

In summary, the new indication for Novo Nordisk's semaglutide by the MHRA represents a significant advancement in the treatment of obesity and related cardiovascular conditions. With the drug’s proven efficacy in reducing the risk of severe heart problems, it offers a promising solution for individuals struggling with obesity and its associated health risks.