FDA committee to discuss anti-NGFs

FDA's Arthritis Advisory Committee will meet on Sept. 13 to discuss safety issues possibly related to anti- nerve growth factor (NGF) compounds. The agency will ask the committee to determine whether reports of joint destruction indicate a safety signal for the class and whether the risk-benefit balance for these compounds favors continued development as analgesics.

Last year, FDA placed clinical holds on at least three anti-NGF pain candidates due to safety concerns for the class: fulranumab ( AMG 403) from Johnson & Johnson (NYSE:JNJ) and Amgen Inc. (NASDAQ:AMGN); REGN475/ SAR164877 from Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) and sanofi-aventis Group (Euronext:SAN; NYSE:SNY); and tanezumab from Pfizer Inc. (NYSE:PFE). In May, FDA lifted a clinical hold on a Phase II trial of fulranumab for cancer pain; the osteoarthritis (OA) indication remains under clinical hold. Amgen was off $0.39 to $54.66 on Monday. Regeneron was up $0.21 to $55.80. ...