BioCentury
ARTICLE | Company News

FDA places fulranumab on hold

December 28, 2010 11:50 PM UTC

FDA placed a clinical hold on pain candidate fulranumab ( AMG 403) from Johnson & Johnson (NYSE:JNJ) and Amgen Inc. (NASDAQ:AMGN) due to concerns that the anti- nerve growth factor (NGF) class may be associated with rapidly progressive osteoarthritis (OA) or osteonecrosis. Fulranumab, a humanized IgG2 mAb against NGF, is in Phase II testing to treat chronic and neuropathic pain. On Monday, FDA placed a clinical hold on another mAb against NGF, REGN475/ SAR164877 from Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) and sanofi-aventis Group (Euronext:SAN; NYSE:SNY). Amgen was down $0.48 to $55.96 on Tuesday. ...