European Commission approves Novo Nordisk’s Saxenda (liraglutide 3.0 mg) for obesity – March 24, 2015

Novo Nordisk announced yesterday that the European Commission has granted marketing authorization for its obesity drug Saxenda (liraglutide 3.0 mg) in all 28 EU member states. Notably, consistent with January’s positive CHMP opinion, the approved label includes prediabetes as an example of a weight-related comorbidity. Specifically Saxenda is indicated as an adjunct to a reduced-calorie diet and increased physical activity for weight management in obese adults (BMI of ≥30 kg/m2) and overweight adults (BMI of ≥27 kg/m2 to <30 kg/m2) who have at least one weight-related comorbidity such as dysglycemia (prediabetes or type 2 diabetes), hypertension, dyslipidemia, or obstructive sleep apnea. We are very glad to see prediabetes included in the European label, as we were disappointed that the US label excluded any mention of the drug’s benefits in that population in the SCALE Obesity and Prediabetes trial – which seems ridiculous, given that is a clear, major benefit of the drug (it’s also not on Vivus’ Qysmia label even though the pre-diabetes data is very strong there too). Novo Nordisk expects to launch Saxenda in several European markets starting this year; we also recently learned that Saxenda could be launched in the US in April. Also excitingly, this news marks the first obesity drug approval in Europe since orlistat (which we see as a non-option due to its challenging side effect profile) in 1998, as Vivus’ Qsiva (phentermine/topiramate; known as Qsymia in the US) and Arena/Eisai’s Belviq (lorcaserin) both failed to receive EMA approval in recent years. As a reminder, Orexigen’s Mysimba (naltrexone/bupropion; known as Contrave in the US) also received a positive CHMP opinion in December, meaning another approval should be on its way in the near future. These regulatory successes suggest that the tide seems to have finally turned for some obesity drugs in Europe, and we are grateful that patients will have access to more treatment options as obesity rates continue to rise – although we expect reimbursement in the EU to be broadly quite poor at the start. Please see our coverage of the recent positive CHMP opinions of Mysimba and Saxenda for more detail on the European obesity landscape; we hope to be back with more on Saxenda in Europe once the full label is available.