Tokyo, Japan and London, England, April 21 2006 - Astellas Pharma Inc. ("Astellas"; headquarters: Tokyo; President and CEO: Toichi Takenaka) today announced that the European Commission has approved the immunosuppressant Prograf® (generic name: tacrolimus) for the prophylaxis use of transplant rejection in recipients of heart transplants in all EU countries*.This outcome is a result of the European Commission's decision to harmonise the summary of product characteristics (SPC) of Prograf® across all EU member states. The immunosuppressive calcineurin inhibitor Prograf® is already indicated for the prophylaxis of organ rejection in kidney and liver transplant patients in EU countries.
Prograf® is an immunosuppressant discovered and developed by Astellas and is marketed in more than 70 countries as an immunosuppressant for organ transplantation. Since the SPC for Prograf® differed in various European countries, Astellas commenced a harmonization of the SPC across EU Member States. The Committee for Medicinal Products for Human Use (CHMP), an organization responsible for scientific assessment of drugs under the European Medicines Agency (EMEA), concluded a referral procedure for Prograf® with a recommendation to harmonize the SPC across EU Member States in January 2006 and an official approval was granted by the European Commission on April 19.
This significant progress in the practice of solid organ transplantation is positive news for heart transplant patients. With proven efficacy and safety benefits in heart transplantation, as well as excellent patient and graft survival rates 1,2, Prograf® is a step forward in the improvement of long-term outcomes for patients.
*The Committee for Medicinal Products for Human Use (CHMP), an organization responsible for scientific assessment of drugs under the European Medicines Agency (EMEA), concluded a referral procedure for Prograf® with a recommendation to harmonize the SPC across EU Member States in January 2006 and an official approval was granted from the European Commission on April 19, 2006. Prior to this harmonisation, Prograf was only licensed for use in heart transplantation in the EU within Belgium and Luxembourg.
This expanded indication is supported by evidence from two large clinical trials published this month in Europe and the US involving a total of 657 patients.1,2
Prograf® has been marketed in North America, Europe, Japan, and Asia, and is commercially available in more than 70 countries.
Prograf® is recognized worldwide as the gold standard of care for the prevention of organ rejection in patients undergoing kidney or liver transplantations and has been the cornerstone of immunosuppressive schemes. Pivotal research conducted in collaboration with many international transplant centres helped to establish Prograf® as a product with high efficacy and several important safety advantages.
Astellas Pharma Europe Limited is a subsidiary of Astellas Pharma Inc., located in Tokyo. Astellas is a pharmaceutical company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceutical products. Astellas Pharma Inc. was formed in April 2005 through the merger of Fujisawa Pharmaceutical Co. Ltd and Yamanouchi Pharmaceutical Co. Ltd. The organisation is committed to becoming a global pharmaceutical company by combining outstanding R&D and marketing capabilities and continuing to grow in the world pharmaceutical market.
1. Grimm M, Rinaldi M, Yonan NA et al.(2006) Superior Prevention of Acute Rejection by Tacrolimus versus Ciclosporin in Heart Transplant Recipients - a Large European Trial. Am. J Transplant - In press
2. Kobashigawa JA et al. (2006) Tacrolimus with Mycophenolate Mofetil (MMF) or Sirolimus vs. Ciclosporin with MMF in Cardiac Transplant Patients: 1-year report. Am J Transplant - In press