Scrip is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


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.



Related Companies




Ask The Analyst

Please Note: Click here for more information on the Ask the Analyst service.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts