Tokyo, July 28, 2011 - Astellas Pharma Inc. (“Astellas”; headquarters: Tokyo; President and CEO: Yoshihiko Hatanaka) announced today that it was granted approval for the additional indication of the prophylaxis of organ rejection in patients receiving allogeneic small bowel transplants, for Prograf® and Graceptor® (generic name: tacrolimus hydrate), in Japan.
Tacrolimus is an immunosuppressant discovered and developed by Astellas and is marketed as an immunosuppressant for organ transplantation under the brand name Prograf in *97 countries/areas. In Japan, Prograf was also approved for bone marrow transplantation, myasthenia gravis, rheumatoid arthritis, lupus nephritis, and ulcerative colitis. Additionally, a once-daily oral formulation of tacrolimus is available in *39 countries/areas worldwide, including Japan under the brand name Graceptor® and Europe under the brand name Advagraf®.
Astellas expects to provide the first therapeutic option to the prophylaxis of organ rejection in patients receiving allogeneic small bowel transplants in the Japanese market.
The impact from this approval on Astellas’ financial forecast for the current fiscal year (from April 1, 2011 to March 31, 2012) will be immaterial.
* as of June 2011