Oslo, Norway – [2025.04.01] – Navamedic is pleased to announce that the European Medicines Agency’s (EMA) human medicines committee (CHMP) has concluded its review of Mysimba (naltrexone/bupropion), affirming that the benefits of the medicine continue to outweigh its risks for weight management in adults with obesity or overweight.

The CHMP has determined that there are no cardiovascular safety concerns for Mysimba when used for up to 12 months. The CHMP has agreed that an ongoing safety study with Mysimba in patients with obesity or overweight is appropriate to generate evidence about this risk in the long term.

The ongoing safety study, INFORMUS, which is set to provide results by 2028, will offer valuable insights into the long-term cardiovascular safety of Mysimba. Annual reports will be submitted to ensure continuous evaluation and transparency.

Navamedic will continue to work closely with healthcare providers to ensure that they are informed of updated guidelines. Healthcare providers should carry out an annual assessment of their patients whether Mysimba remains beneficial for them.

Kathrine Gamborg Andreassen, CEO of Navamedic, commented on the review: “We are encouraged by the CHMP's conclusion that Mysimba remains a beneficial option for weight management. At Navamedic, patient safety is our utmost priority, and we are committed to contribute to and ensure the long-term safety and efficacy of Mysimba.”

www.ema.europa.eu/en/news/ema-concludes-review-weight-management-medicine-mysimba

INFORMUS Safety Study: https://clinicaltrials.gov/study/NCT06098079