The United States unit of Novartis AG has filed for marketing approval with the U.S. Food and Drug Administration for Simulect, a monoclonal antibody that has been reported to help lessen the incidence of kidney rejection.
Simulect, the company’s trade name for basiliximab, is a selective high-affinity antibody that blocks the receptor for a protein that stimulates the proliferation of white blood cells.
According to Reuters, Novartis’ submission to the FDA included data from two phase III clinical trials that involved 729 renal transplant recipients in the United States and Europe.
Dr. Björn Nashan of Medizinische Hochschule Hannover, Germany, and his colleagues reported on October 25 in The Lancet that Simulect, taken in two doses within four days of kidney transplantation, reduced the incidence of acute rejection by 32%. See related story.
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