The European Commission has granted approval for Novartis to market Simulect (basiliximab) in the European Union for the prevention of acute rejection of transplanted kidneys.
The approval comes about five months after the Food and Drug Administration approved the marketing of Simulect for the same purpose in the United States.
"Simulect will be the first drug of its kind to become available in the EU in the coming months," Novartis said in a statement.
Simulect is a monoclonal antibody that enhances the immunosuppressive effect of Novartis' Neoral. "Because of its high, specific affinity for the cells that attack the transplant in the rejection process, only two doses of Simulect are required: one before and the other a few days after transplantation," Novartis said.
Transplant News Network reported on June 1 that in phase III clinical trials in 729 patients, two doses of Simulect used with cyclosporine and corticosteroids proportionately reduced the incidence of rejection by 31% during the six months following kidney transplantation.
Please be aware that medical advice, diagnoses and physician references cannot be obtained from this site.