Prograf is currently approved for the prevention of kidney, liver and heart transplant recipients in the US. The FDA sent Japanese company Astellas an approvable letter over concerns that the combination of the two drugs may lead to an increase in deaths from infection, based on the review of a clinical study.
The study, published in the American Journal of Transplantation, said that the one year survival rate for kidney transplant patients on Prograf/CellCept was 95.7%, 97.6% in the cyclosporine modified and CellCept arm, and 98.6% in the extended release Prograf/CellCept arm.
However, Astellas said that peer-reviewed literature has not shown any significant differences in survival rates among patients receiving the combination of CellCept with Prograf or anti-rejection drug cyclosporine with Prograf. Astellas said that it would work with the FDA to resolve the differences in interpretation of the data and pursue approval of its supplemental new drug application.