EMA concludes review of weight management medicine Mysimba (naltrexone / bupropion) – Currax Pharmaceuticals

EMA’s human medicines committee (CHMP) has finalised its review of Mysimba (naltrexone / bupropion), a medicine used for weight management in adults with obesity or overweight. The review was prompted by concerns about a potential long-term cardiovascular risk (risk affecting the heart and blood circulation) with the medicine. The CHMP has concluded that the benefits of Mysimba  ( Contrave ) continue to outweigh its risks.

However, the company must provide more information from an ongoing study on the medicine’s cardiovascular effects in patients treated for longer than one year. New measures are also being implemented to minimise potential cardiovascular risks with long-term use. At the time of Mysimba’s authorisation, the CHMP noted uncertainties regarding the long-term effects of Mysimba on the cardiovascular system. To date, studies have shown that there is no cardiovascular safety concern when Mysimba is used for up to 12 months. However, the data available are not sufficient to fully determine the cardiovascular safety beyond this time. The CHMP has agreed that an ongoing safety study with Mysimba in patients with obesity or overweight carried out by the company is appropriate to generate evidence about this risk in the long term. The results are expected in 2028 b and the company (now  Currax Pharmaceuticals) must provide annual reports on the progress of the study. The CHMP has imposed this study as a condition to the marketing authorisation.