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EMA backs Wegovy cardiovascular label update as Novo seeks EU coverage
26 Jul 2024
Clinical ResultDrug ApprovalPhase 3Vaccine
The EMA’s CHMP gave a positive opinion for a Wegovy label expansion, allowing the therapy’s use for the reduction of cardiovascular events such as heart failure. Credit: ARVD73 via Shutterstock.
The EMAopean Medicines Agency (EMA) has offered a positive opinion to Novo Nordisk, which should pave the way for the company to update the label fheart failureuster weight loss drug Wegovy (semaglutide 2.4mg).
The European Medicines Agency (EMA)apy’s positive effects on cardiovasNovo Nordisk, potentially improving its chances for reimbursement in Europe.Wegovysemaglutide
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) suppWegovythe label update based on data from the Phase III SELECT (NCT03574597) study. The trial demonstrated that Wegovnon-fatal heart attacknce non-fatal strokeatistically significant manncardiovascular disease placebo with standard of care.diabetes
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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 uEMAr 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 cardiovascularFood and Drug Administrationscular 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 betweeWegovy/m² and 30kg/m², alongside an additional approval for adolescents over 12 years and above with obesity.
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