sNDA has granted approval for Astellas’ moderately/severely refractory ulcerative colitis, as additional indication for the immunosuppressant Prograf (tacrolimus hydrate). The company had submitted a sNDA to the Pharmaceuticals and Medical Devices Agency (PMDA) in June 2008 in Japan.
Tacrolimus is an immunosuppressant discovered and developed by Astellas. It is marketed as an immunosuppressant for organ transplantation under the brand name – Prograf, in more than 80 countries.
In Japan, Prograf was also approved for bone marrow transplantation, systemic myasthenia gravis, rheumatoid arthritis, and lupus nephritis. A once-daily oral formulation of tacrolimus is available in 25 countries worldwide, including Japan under the brand name – Graceptor, and Europe under the brand name – Advagraf.
Astellas believes this approval would contribute towards the medical treatment of ulcerative colitis in Japan.