Mysimba Shows Positive Benefit-Risk Profile for Cardiovascular Safety

The European Medicines Agency (EMA) has reaffirmed the positive benefit-risk profile of Mysimba concerning cardiovascular risks, albeit for a limited duration of one year. The medication combines the opioid antagonist naltrexone and the amphetamine bupropion, primarily utilized in conjunction with a diet and physical exercise for weight management in adults suffering from obesity or overweight, particularly those experiencing weight-related complications such as diabetes, elevated cholesterol levels, or hypertension. Initially approved in Germany in 2018, Mysimba is not currently available in the German market.

The review was prompted by existing concerns regarding potential long-term cardiovascular risks associated with the medication, which were identified at the time of its approval. Following a comprehensive evaluation, the Committee for Medicinal Products for Human Use (CHMP) of the EMA concluded that there are no indications of cardiovascular safety issues when Mysimba is taken for up to twelve months. However, the existing data are insufficient to ascertain the drug's cardiovascular safety beyond this period, as stated in an official press release from the EMA.

The manufacturer is mandated to provide annual data on the cardiovascular effects of Mysimba from an ongoing study, INFORMUS, which includes 8,600 participants receiving either Mysimba or a placebo. This Phase IV study is crucial for monitoring the drug's long-term impact on cardiovascular health.

Additionally, measures have been implemented to mitigate potential cardiovascular risks associated with long-term use of Mysimba. For instance, treatment should be discontinued after one year if patients do not achieve and maintain a weight loss of at least 5% of their initial body weight.