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US FDA complete response letter for BMS's belatacept

This article was originally published in Scrip

Executive Summary

Bristol-Myers Squibb has received a US FDA complete response letter for its injectable immunosuppressant belatacept, requesting longer-term clinical data for the product. It has been filed for the prevention of organ rejection and the preservation of a functioning allograft following kidney transplantation in adult patients when used in combination with an interleukin-2 receptor antagonist, a mycophenolic acid and corticosteroids.

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