Sevirumab (Protovir®, MSL 109, EV2 7, SDZ MSL 109) is a human anticytomegalovirus (CMV) monoclonal antibody directed to a conformational epitope of the envelope glycoprotein H (gpH). In 1993, Novartis who originally developed sevirumab, licensed North American and Asian rights to Protein Design Laboratories. Novartis and Protein Design Laboratories share certain copromotion and co-marketing rights in these countries. The compound was exclusively licensed to Corange (Boehringer Mannheim) for Europe and the rest of the world; however, rights have now returned to Protein Design Labs.Phase II trials for CMV retinitis have been completed in Switzerland and the US. A further phase II study, sponsored by the National Institute of Allergy and Infectious Diseases AIDS Clinical Trials Group (ACTG), has been halted as the use of higher doses of sevirumab were indicated. The study,which was evaluating sevirumab as an adjunctive treatment to ganciclovir or foscarnet in AIDS patients with newly diagnosed CMV retinitis, had enrolled approximately half of the anticipated 167 patients. The ACTG had reportedly recommended the trial continue, but with higher doses of sevirumab than the 15 and 60mg doses originally used. A phase II/III study being conducted by the Studies of the Ocular Complications of AIDS (SOCA), a study group affiliated to the National Eye Institute in the US, was also halted because of lack of efficacy. The sevirumab dose used in that study was 60mg. A previous study demonstrated a delay in disease progression of 60 to 100 days.Aphase II/III trial is being conducted to investigate the effect of sevirumab in the prevention of CMV infection in patients undergoing bone marrow transplantation.Results from phase II trials show sevirumab to have potential in the treatment of CMV disease in combination with foscarnet or ganciclovir. Compared with foscarnet and ganciclovir, sevirumab appears to have a wider margin of safety and is well tolerated with no anti-monoclonal antibody immune responses.