The European Medicines Agency (EMA) has offered a positive opinion to Novo Nordisk, which should pave the way for the company to update the label for its blockbuster weight loss drug Wegovy (semaglutide 2.4mg).
The new label will reflect the therapy’s positive effects on cardiovascular health, potentially improving its chances for reimbursement in Europe.
Under the new label, healthcare providers will be able to prescribe Wegovy to patients to reduce the risk of major adverse cardiovascular events (MACE), including cardiovascular death, non-fatal heart attack or non-fatal stroke in adults with established cardiovascular disease. If approved, this will be available for patients who are overweight or obese (initial BMI ≥27kg/m²) without having diabetes.
The EMA’s Committee for Medicinal Products for Human Use (CHMP) supported the label update based on data from the Phase III SELECT (NCT03574597) study. The trial demonstrated that Wegovy decreased the incidence of MACE, in a statistically significant manner, by 20% compared to placebo with standard of care.
Additionally, the drug reduced the risk of cardiovascular death and death from any cause by 15% and 19%, respectively. An 18% risk reduction was also noted in a composite endpoint that considered heart failure and other related factors.
The positive recommendation arrives after several months of EMA deliberation. The EU regulator initially convened a panel to discuss the potential label update in January, but concluded that supplementary information would be necessary before the decision could be made. The US Food and Drug Administration approved a similar label expansion in March 2024.
The new label expansion may help the drug’s case for reimbursement and insurance coverage in more European countries. A few weeks ago, the Dutch Healthcare Institute chose not to recommend the coverage of Wegovy under the country’s basic insurance system, saying it was uncertain whether the drug’s effects justified its coverage.
In a 17 July article, a Novo Nordisk spokesperson responded to a related Reuters report saying: “While we are pleased that the Dutch Health Care Institute recognises the necessary role of medications in the fight against obesity as a chronic disease, we are obviously disappointed in their initial decision."
Germany is also yet to reimburse any weight loss therapies under its national system. However, G-BA, the German healthcare regulator, said that the drugs could not be approved for weight loss alone, but could be considered for reimbursement “to reduce the risk of cardiovascular events after prior cardiovascular disease,” in a 21 March guidance.
Novo Nordisk has so far received EU approvals for Wegovy’s use for weight loss in patients with a body mass index (BMI) of 30kg/m² or above with obesity, and patients with type 2 diabetes with a BMI between 27kg/m² and 30kg/m², alongside an additional approval for adolescents over 12 years and above with obesity.
