in Phase III, expected to submit to FDA in first half of 2009; positive Phase III data reported 6/09, compared to cyclosporin; BLA accepted by NDA 9/09; FDA advisory board scheduled for 3/1, with PDUFA date 5/1/10; prior to advisory board, FDA notes that drug demonstrated better survival rates, improved kidney function and lower blood pressure; however, concerns were raised re: higher rate of severe kidney rejections and instances of PML (2/10); recommended by FDA advisory board in a 13-5 vote (3/10); Complete response letter received 4/10 requesting 36-month data from the ongoing Phase 3 studies to further evaluate the long-term effects, as well as information to support the company's manufacturing and the proposed risk evaluation and mitigation strategy
Brand N/A Generic belatacept (BMS-224818)
Company name Bristol-Myers Squibb Product type Speciality
Therapeutic category Immunological agents Key uses renal transplantation
Other Uses N/A Drug Class fusion protein immunosuppressant
Dosage From IV Expected Approval 2011-Q1
FDA Filing 9/09 Last Update date May 28,2010
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