EC approves Rebif indication revision

Swiss drugmaker Serono says that the European Commission has approved an update of the Summary of Product Characteristics for its multiple sclerosis treatment Rebif (interferon beta-1a). The revision allows the prescribing of the drug to MS patients in Europe who have had their condition confirmed by the occurrence of one disease attack.

The update relates to the therapeutic indication section of the SmPC, which now takes into account the McDonald criteria for MS diagnosis, and specifically the use of a confirmatory magnetic resonance imaging scan. Previously, this section was based on the Poser criteria that were in use at the time of the drug's approval in 1998, which limited the product's use to patients who had suffered a minimum of two attacks.

Roberto Gradnik, Serono's European senior executive vice president, said: "MS has an initial stage when clinical manifestations are not pronounced but irreversible neurological damage is taking place." He added that this early-stage damage determines a patient's risk of disease progression, and that the EC's decision would allow physicians in the region to begin treatment of MS at an earlier stage, when it is needed most. The update is valid immediately in all 25 member states of the European Union.