Astellas Pharma Inc. has obtained an approval from the ministry of health, labour and welfare (MHLW) for the immunosuppressant Prograf capsules 0.5mg/1mg (generic name: tacrolimus hydrate) for the new indication of the treatment of rheumatoid arthritis in patients who respond insufficiently to current therapies in Japan on April 11, 2005.

Prograf has been available in Japan since June 1993 and is currently used for the prophylaxis of organ rejection in transplant recipients, the prophylaxis of rejection in bone marrow transplant recipients, and the treatment of generalized myasthenia gravis. A supplemental application for the treatment of rheumatoid arthritis was submitted in Japan in November 2002 and approved on April 11, 2005. Prograf capsules is now available for this new indication, the company release said.

Prograf works via suppression of activation and proliferation of T-lymphocytes as well as permeation of inflammatory cells by inhibiting cytokine production by T-lymphocytes.