Astellas Pharma Inc.today announced that it has received a Japanese marketing approval for the immunosuppressant Graceptor Capsules 0.5mg, 1mg, 5mg

Japan | July 17, 2008 | Astellas Pharma Inc. (headquarters: Tokyo, president and CEO: Masafumi Nogimori, “Astellas”) today announced that it has received a Japanese marketing approval for the immunosuppressant Graceptor® Capsules 0.5mg, 1mg, 5mg (generic name: tacrolimus hydrate) (FK506 Modified Release Formulation) for “suppression of organ rejection” and “suppression of graft rejection and GVHD in bone marrow transplantation.” A New Drug Application had been submitted in May 2006.

Graceptor is a once-daily modified release formulation of Astellas’s Prograf® (tacrolimus, twice-daily formulation). Tacrolimus works as an immunosuppressant by inhibiting production of cytokine including differentiation/growth factor secreted from T-cell, interleukin-2 and interferon-gamma. Once-daily administration of Graceptor is expected to improve long-term compliance with its more convenient once-daily dosing option, and may have the potential to reduce the incidence of graft loss. The European
Committee has granted an European Marketing Authorisation for a once-daily formulation of Prograf in April 2007. It has been available with the brand name Advagraf® throughout Europe starting with the UK and Germany since June 2007. It is currently marketed in 18 countries worldwide including Canada.

Astellas expects to provide a new option for transplant medication with the new lineup for Prograf family. The launch timing will be announced after it appears in the NHI Drug Price List.

SOURCE: Astellas Pharma Inc.
 

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