EMA Supports Wegovy Cardiovascular Label Update as Novo Pursues EU Coverage

The European Medicines Agency (EMA) has given a favorable opinion to Novo Nordisk, potentially enabling the company to update the label for its widely used weight-loss drug, Wegovy (semaglutide 2.4mg). This update would highlight the drug's benefits for cardiovascular health, possibly enhancing its likelihood of reimbursement across Europe.

With the proposed label, healthcare providers could prescribe Wegovy to lower the risk of significant adverse cardiovascular events (MACE) such as cardiovascular death, non-fatal heart attacks, or non-fatal strokes in adults with established cardiovascular disease. This would apply to patients who are overweight or obese (initial BMI ≥27kg/m²) and who do not have diabetes.

This recommendation from the EMA’s Committee for Medicinal Products for Human Use (CHMP) is based on data from the Phase III SELECT study (NCT03574597). The trial showed that Wegovy significantly reduced the occurrence of MACE by 20% compared to a placebo with standard care. Additionally, the drug reduced the risk of cardiovascular death and overall mortality by 15% and 19%, respectively. An 18% reduction was also noted in a composite endpoint that included heart failure and related issues.

The positive recommendation comes after months of deliberation by the EMA. Initially, a panel was convened in January to discuss the label update, but more information was deemed necessary before a decision could be made. The US Food and Drug Administration approved a similar label expansion in March 2024.

The new label expansion could bolster the drug’s case for reimbursement and insurance coverage in more European countries. Recently, the Dutch Healthcare Institute decided not to recommend Wegovy coverage under the country’s basic insurance system, citing uncertainty about whether the drug’s effects warranted such coverage. In a response to a Reuters report, a Novo Nordisk spokesperson expressed disappointment but noted that the Dutch Health Care Institute acknowledged the critical role of medications in combating obesity as a chronic disease.

Germany has also yet to approve reimbursement for weight-loss therapies under its national system. However, the German healthcare regulator, G-BA, stated that these drugs could be considered for reimbursement to reduce the risk of cardiovascular events following prior cardiovascular disease, according to a guidance issued on March 21.

Novo Nordisk has already received EU approvals for Wegovy for weight loss in patients with a body mass index (BMI) of 30kg/m² or higher with obesity, and for patients with type 2 diabetes with a BMI between 27kg/m² and 30kg/m². There is also approval for adolescents aged 12 and above with obesity.