In Europe, Changes to Liraglutide Label to Reflect LEADER

Miriam E Tucker

June 28, 2017

European regulators have moved to add the results of the landmark Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome Results—A Long Term Evaluation (LEADER)  trial to the labeling of liraglutide (Novo Nordisk's Victoza [1.8 mg] and Saxenda [3 mg]).

LEADER, announced in 2016, showed that liraglutide (1.8 mg) significantly reduced the rates of major adverse cardiovascular events in type 2 diabetes patients at elevated cardiovascular risk.

On June 23, 2017, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency endorsed an update to the label for Saxenda (the higher-dose product marketed for the treatment of obesity) to include LEADER data (13% and 22% reductions in cardiovascular events and death, respectively) and also issued a positive opinion to add cardiovascular risk reduction as a new indication to the label for Victoza (already approved for the treatment of type 2 diabetes).

The CHMP previously concluded that although the 3-mg dose of liraglutide that constitutes the weight-loss product Saxenda was not investigated in the LEADER trial, the results would also be supportive of the assessment of Saxenda for any potential cardiovascular risk and therefore is effective immediately.

The Saxenda label has been updated with immediate effect to reflect the primary outcome of the LEADER trial, says Novo Nordisk. Saxenda is indicated as an adjunct to a reduced-calorie diet and increased physical activity for weight management in adult patients with an initial BMI of > 30 kg/m2 (obese), or > 27 kg/m2 to < 30 kg/m2 (overweight) in the presence of at least one weight-related comorbidity such as dysglycemia (prediabetes or type 2 diabetes), hypertension, dyslipidemia, or obstructive sleep apnea.

"This is an important development for people with obesity in Europe living with weight-related comorbidities such as cardiovascular disease," the company adds.

And while it may seem strange that the Saxenda label in the European Union has been updated to include the LEADER data before that of Victoza, a Novo Nordisk spokesperson told Medscape Medical News that the recent CHMP positive opinion to update the Victoza EU label covers both glycemic control and CV-event reduction as integral parts of type 2 diabetes treatment.

Positive opinions from the CHMP are usually formally approved within 60 days.

The European regulatory moves follow a June 20 US Food and Drug Administration advisory panel vote to recommend liraglutide for the additional indication of an "adjunct to standard treatment of cardiovascular risk factors to reduce the risk of major adverse cardiovascular events (cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke) in adults with type 2 diabetes mellitus and high cardiovascular risk."

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