Serono received approval from the European Commission for an update of the Summary of Product Characteristics (SmPC) of Rebif, in order to align it with current medical practice. In the EU, Rebif can now be prescribed after the diagnosis of multiple sclerosis (MS) has been confirmed based on one attack and subsequent positive magnetic resonance imaging (MRI) scans.
The 'therapeutic indication' section of the SmPC of Rebif now takes into account the McDonald criteria, which are the current reference criteria for the diagnosis of MS. The McDonald criteria utilize MRI evidence as an alternative to a second attack, and allow the same patients to be diagnosed with more sensitivity and specificity. Current understanding of the disease supports that it is critical to initiate treatment as soon as the diagnosis of MS is established to ensure the best possible outcome for the patients.
The updated SmPC of Rebif is valid immediately in all 25 member states of the EU. In most other regions of the world, the therapeutic indication of Rebif already takes into account the McDonald criteria.