Novartis Pharma AG announced that the US Food and Drug Administration has approved the use of Myfortic (mycophenolic acid) delayed release tablets in combination with cyclosporine and corticosteroids to prevent organ rejection in kidney transplant patients.

Myfortic is a new, enteric-coated formulation of mycophenolate acid that delivers the active moiety mycophenolic acid (MPA). This is the same active moiety as delivered by mycophenolate mofetil (MMF, Cellcept), which is taken by over 80 per cent of new kidney transplant recipients in the United States as part of their immunosuppressive regimen.

"Myfortic in combination with Neoral (cyclosporine for microemulsion) gives patients and physicians a treatment option that offers the full benefits of mycophenolic acid therapy in an enteric-coated formulation," Tony Rosenberg, head, Transplantation and Immunology Business Unit, Novartis.

Studies have reported that up to 70 per cent of patients taking MMF required at least one dose change due to drug related side effects. Patients who underwent an initial reduction in MMF dose were eight times more likely to suffer acute organ rejection than those who had not had a dose adjustment. For these patients, enteric-coated Myfortic is a new option.

Results of two global multi-center trials, in more than 700 patients, indicate that Myfortic and MMF are therapeutically equivalent in de novo renal transplant patients and that the conversion to Myfortic from MMF is safe in maintenance renal transplant patients.

Myfortic successfully completed the European Mutual Recognition Procedure (MRP) and was approved for the prevention of acute rejection in kidney allografts (transplants) in adult patients on February 7, 2004. It received its first regulatory approval, from Switzerland, in October 2002.

"The approval of an enteric-coated immunosuppressant like Myfortic is very exciting news for renal transplant patients," said Professor Robert Ettenger, UCLA, Los Angeles. "Different products work for different patients. The availability of more treatment options increases the chances that we can reduce the risk of organ rejection in more patients."

The Novartis Transplantation and Immunology Team is committed to developing a new and innovative range of therapeutic products for the prophylaxis of organ rejection in order to provide the most extensive choice of drugs to the transplant community and to maintain Novartis' role as a global market leader in this field of medicine.