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Japanese launch for once-daily tacrolimus

This article was originally published in Scrip

Executive Summary

Astellaswill launch Graceptor, its once-daily formulation of the immunosuppressant tacrolimus, in Japan on October 28th. The oral product is indicated for organ rejection in kidney, liver, heart, lung and pancreas transplants, and graft rejection and graft-versus-host disease in bone marrow transplantation. It is already marketed (as Advagraf) in 19 other countries but has faced regulatory difficulties in the US, where the patent for Prograf, the standard release product, expired in April. Japanese pricing authorities predict peak annual reimbursement level sales of Graceptor will reach around ¥16 billion ($171.6 million).

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