NEW YORK, May 2 (Reuters) - Bristol-Myers Squibb said that the U.S. Food and Drug Administration issued a complete response letter related to using belatacept in kidney transplants, according to a press release issued on Saturday.
The letter asked for the 36-month data from the ongoing Phase 3 studies to further evaluate the long-term effect of belatacept. The information it already submitted included 24-month data from the Phase 3 studies, the company said.
The FDA also asked for information to support the company's manufacturing and the proposed risk evaluation and mitigation strategy, it said.
An FDA Advisory Committee panel met on March 1 and voted 13 to 5 to recommend approving the use of the drug for kidney transplant recipients. The FDA is not bound by these recommendations.
((Reporting by Caroline Humer, editing by Martin Golan) Keywords: BRISTOLMYERS/ (email Caroline.Humer@Thomson.Reuters.com; Tel: 1-646-223-6181) COPYRIGHT Copyright Thomson Reuters 2010. All rights reserved. The copying, republication or redistribution of Reuters News Content, including by framing or similar means, is expressly prohibited without the prior written consent of Thomson Reuters.
The letter asked for the 36-month data from the ongoing Phase 3 studies to further evaluate the long-term effect of belatacept. The information it already submitted included 24-month data from the Phase 3 studies, the company said.
The FDA also asked for information to support the company's manufacturing and the proposed risk evaluation and mitigation strategy, it said.
An FDA Advisory Committee panel met on March 1 and voted 13 to 5 to recommend approving the use of the drug for kidney transplant recipients. The FDA is not bound by these recommendations.
((Reporting by Caroline Humer, editing by Martin Golan) Keywords: BRISTOLMYERS/ (email Caroline.Humer@Thomson.Reuters.com; Tel: 1-646-223-6181) COPYRIGHT Copyright Thomson Reuters 2010. All rights reserved. The copying, republication or redistribution of Reuters News Content, including by framing or similar means, is expressly prohibited without the prior written consent of Thomson Reuters.