Japan, April 11, 2005 - Astellas Pharma Inc. ("Astellas") today announced that the Company obtained an approval from the Ministry of Health, Labor 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.
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. With its mechanism of action which differs from other antirheumatic drugs, Prograf® capsules is expected to contribute to the treatment of rheumatoid arthritis by offering a new treatment option. Astellas will make full effort to establish the appropriate use of the drug and provide accurate information on the drug to rheumatoid arthritis specialists.