Abstract :
Enteric-coated mycophenolate sodium (ECMS) (Myofortic®, Novartis Inc.) was approved by the Saudi Arabian Ministry of Health in April 2003, shortly after this new product was received its first regulatory approval in Switzerland in October 2002. Since then, ECMS has gained approval in more than 36 countries around the world. ECMS also complied with the European Mutual Recognition Procedure (MRP) and was approved for the prevention of acute rejection in kidney allografts in adult patients in February 2004. Also, in March 2004, the U.S. Food and Drug Administration (FDA) approved it to be used in combination with cyclosporine and corticosteroids to prevent organ rejection in kidney transplant patients. [1] The FDA based its approval on the results of two randomized, multicenter, double-blind clinical trials of more than 700 newly transplanted (de novo) and maintenance renal transplant patients, compared to mycophenolate mofetil (MMF). [2],[3] These studies and some additional recent literature on ECMS and MMF will be reviewed in this article.
