Replies to post #95223 on Biotech Values

[DewDiligence]

Cases Where FDA Rejected a Drug Endorsed by Advisory Panel

[Added Belatacept and Prolia. Note: this
table does not purport to be exhaustive.]

 
                        Panel Vote   Date of FDA    Ultimate     iHub  
 Company    Drug       For Approval  Non-approval   Resolution   Reference 
 AMGN     Prolia*          15-0‡       10/09         pending     #msg-42655799 
 BMY      Belatacept       13-5         5/10         pending     #msg-49686117 
 DNDN     Provenge         13-4         5/07       apprvd 05/10  #msg-19483904 
 ITMN     Pirfenidone       9-3         5/10         pending     #msg-49777513 
 MRK      Bridion          14-0         8/08         pending     #msg-31141155 
 PFE      Oporia            9-3         1/09         pending     #msg-34890112 
 Roche    Actemra          10-1        12/08       apprvd 01/10  #msg-33965815 
  
 *a/k/a denosumab. 
 ‡15-0 vote was for treatment of postmenopausal osteoporosis; 
 vote on prevention of postmenopausal osteoporosis was 12-3.