Raptiva label updated on long-term efficacy

Merck Serono, a division of Germany's Merck KGaA, says that the European Commission has approved an update of the Summary of Product Characteristics for Raptiva (efalizumab) in the treatment of moderate-to-severe chronic plaque psoriasis, a chronic inflammatory systemic disease of the skin.

The decision followed a positive recommendation by the European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use (CHMP), which had previously completed a benefit-risk re-assessment of Raptiva and concluded that the drug's profile remains positive for the approved indication.

The SPC has been amended to include efficacy and safety data on up to three years of continuous treatment with Raptiva, the longest for any approved biological therapy for psoriasis. The clinical efficacy section of the SPC for Raptiva now includes a new sub-heading on long-term treatment, stating that approximately 50% of the responding patients treated for more than one year showed a 75% improvement in the disease, as measured by the standard Psoriasis Area and Severity Index score, when all dropouts were considered as non-responders. No increase in the incidence of serious infections over time was observed.