Mysimba Passes EU Safety Probe, But Currax Must Explore Long-Term Heart Risks

The weight management drug, Mysimba, continues to demonstrate a positive benefit-risk balance but the data available are not sufficient to fully determine the cardiovascular safety beyond 12 months. Meanwhile, Currax this month announced the publication of a peer-reviewed study of Mysimba that followed patients for over 4.7 years and found no evidence of excess cardiovascular risk.

Obese Woman with fat belly in dieting concept.
The weight management drug, Mysimba, has been approved for use in the EU since March 2015 (Shutterstock)
Key Takeaways
  • A European Medicines Agency review into the safety of Mysimba has now concluded, showing that the drug continues to outweigh its risks.
  • That said, Currax Pharmaceuticals will need to provide the EMA with more data on the long-term effect of the product on the heart from its ongoing INFORMUS trial and update its product information.
  • One of the risk minimization measures to be implemented is that treatment with Mysimba should be discontinued after one year if weight loss of at least 5% of the initial body weight is not maintained.

A European Medicines Agency safety probe has found that the benefits of the weight management drug Mysimba continue to outweigh its risks, although Currax Pharmaceuticals will need to provide more...

The agency’s human medicines committee, the CHMP, began the safety review in 2023, prompted by concerns about a potential long-term cardiovascular risk with the medicine,...

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