Novartis announced that it has successfully completed the European Mutual Recognition Procedure (MRP) in 15 countries for Certican (everolimus) for the prevention of rejection episodes following heart or kidney transplantation.
Certican will be indicated for the prophylaxis of organ rejection in adult patients at low to moderate immunological risk receiving an allogeneic renal or cardiac transplant. Certican should be used in combination with ciclosporin for microemulsion and corticosteroids. All countries involved in the MRP are expected to issue a marketing authorization in the coming months. Certican, a novel proliferation signal inhibitor, is the first drug in its class to receive the indication for heart as well as kidney transplants patients.
"Certican is a welcome addition to our established portfolio of marketed products that have enhanced the lives of transplant recipients," said Tony Rosenberg, head, transplantation and immunology business unit, Novartis Pharma AG. "Certican could offer transplant patients and physicians a powerful tool to improve long-term survival through its ability to reduce the incidence and severity of the primary causes of rejection."
Certican is a novel proliferation signal inhibitor with immunosuppressant properties that targets primary causes of allograft dysfunction also known as chronic rejection of a transplanted organ), including acute rejection and vascular remodeling. In addition, Certican is used with low dose ciclosporin. Preventing allograft dysfunction is a major unmet medical need in transplantation.
"The availability of Certican marks another step forward for individuals requiring transplantation," said professor Mario Vigano, professor of cardiac surgery, San Matteo Hospital, Pavia, Italy, and a lead investigator for Certican in heart transplant. "As each promising new agent becomes available, opportunities to improve short- and long-term survival after transplantation are renewed. We anticipate that Certican will contribute importantly to the well being of patients requiring this remarkable therapy."
The European countries' decision under the MRP is based on data from studies which comprised 634 heart transplant patients for 24 months and more than 1700 kidney transplant patients for up to 36 months. Results demonstrated that Certican effectively prevented graft rejection when administered with Neoral and corticosteroids.
At the completion of the MRP, the following 15 countries have endorsed the mutually agreed summary of product characteristics (SmPC): Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, and Sweden. Certican received its first approval from the Swedish Medical Products Agency in July 2003 for the prevention of rejection in heart and kidney transplant patients in combination with Neoral and corticosteroids. Sweden is the Reference Member State for the Mutual Recognition Procedure.
The Novartis transplantation and immunology business unit is committed to developing an innovative range of therapeutic products for the prevention of organ rejection in order to provide an extensive choice of drugs to the transplant community and to maintain Novartis' role as a global market leader in this field of medicine.