Saxenda and Mysimba Approved in Europe, the First Obesity Drugs Since 1998

Twitter Summary: Saxenda & Mysimba (Contrave in US) now approved in Europe for #obesity, first since 1998

The European Commission recently approved Saxenda (liraglutide 3.0 mg; once-daily injection) and Mysimba (naltrexone/bupropion; twice-daily pills known as Contrave in the US) for weight-management, meaning both can now be marketed in all 28 European Union member states. These drugs are meant to be used as an add-on to diet and exercise in obese adults (BMI greater than 30), or those who are overweight (BMI greater than 27) with at least one weight-related issue such as type 2 diabetes, high blood pressure, high cholesterol, or obstructive sleep apnea. Novo Nordisk plans to launch Saxenda in several European countries starting this year, and the medication could be launched in the US as early as April. Contrave is already available in the US.

Notably, the label for Saxenda includes prediabetes as a case of abnormal blood sugars, a departure from the US label that does not include any mention of Saxenda’s potential benefits for people with prediabetes. In clinical trials, participants with prediabetes on Saxenda were more likely to revert to normal glucose levels (meaning no diabetes or prediabetes at all!) after one year compared to those on placebo (69% of participants on Saxenda vs. only 33% on placebo). 

The approval of both obesity drugs within one week is a dramatic shift for the European regulatory environment, as these are the first obesity drugs approved in Europe since 1998. One concern will be reimbursement, which is expected to be relatively low in Europe to start. Please read more about Saxenda for use in weight-management, trial results in people with obesity, and personal experiences with the drug in our coverage of its FDA approval here, as well as more on Contrave here. –NL