Merck Serono (GENEVA, SWITZERLAND), a division of Merck KGaA, announced that the European Commission has approved an update of the Summary of Product Characteristics (SPC) for Raptiva^® (efalizumab) in the treatment of moderate-to-severe chronic plaque psoriasis. The decision followed a positive recommendation by the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMEA), which had previously completed a benefit:risk reassessment of Raptiva. The CHMP had concluded, based on the clinical and postmarketing data submitted by Merck Serono, that the benefit:risk profile remains positive for the population in the approved indication.

The SPC has been amended to include efficacy and safety data on up to 3 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 subheading on long-term treatment, stating that ~50% of the responding patients treated >1 year showed a 75% improvement in the disease, as measured by the standard Psoriasis Area and Severity Index (PASI) score (PASI-75), when all dropouts were considered as nonresponders. Regarding undesirable effects, no increase in the incidence of serious infections over time was observed. There was also no evidence of increased risk of any particular malignancy over time with the exception of nonmelanoma skin cancer. These data support a long-term favorable safety profile of Raptiva up to 3 years. The decision of the European Commission means that the updated SPC for Raptiva is valid immediately in all member states of the EU. The amendments to the SPC will also be introduced in the package leaflet.

Raptiva is designed to be administered once-weekly via subcutaneous injection and can be self-administered by patients at home. Raptiva received EU approval for the treatment of adult patients with moderate-to-severe chronic plaque psoriasis who have failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporine, methotrexate, and phototherapy (PUVA). Raptiva safety data have now accumulated for 10 years of clinical development and postmarketing experience in psoriasis patients. The marketing authorization holder of Raptiva in the EU is Serono Europe Ltd, an affiliate of Merck Serono SA Merck Serono has the rights to develop and market Raptiva worldwide outside of the US and Japan. To date, Raptiva is available in 66 countries, including many countries in Europe, Latin America, and Asia as well as Australia and Canada. Raptiva is licensed from Genentech, Inc, and Genentech retains development and marketing rights in the US, where Raptiva has been available since November 2003.

Raptiva is an immunosuppressive recombinant humanized IgG1 kappa isotype monoclonal antibody that binds to human CD11a, the  -subunit of leukocyte function antigen-1 (LFA-1), and selectively and reversibly blocks the activation, reactivation, and trafficking of T-cells. Raptiva inhibits the binding of LFA-1 to intercellular adhesion molecule-1 (ICAM-1), thereby inhibiting the adhesion of leukocytes to other cell types. Interaction between LFA-1 and ICAM-1 contributes to the initiation and maintenance of multiple processes, including activation of T-lymphocytes, adhesion of T-lymphocytes to endothelial cells, and migration of T-lymphocytes to sites of inflammation. In psoriatic skin, ICAM-1 cell surface expression is upregulated on endothelium and keratinocytes.