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FDA panel to consider role of anti-NGF compounds

March 9, 2012 12:45 AM UTC

FDA will ask its Arthritis Advisory Committee on Monday whether there are any populations for which anti- nerve growth factor (NGF) pain products should be developed, given reports of joint destruction seen in clinical trials. According to draft questions posted Thursday, the agency will ask if the compounds should be studied only in patients refractory to standard of care or only in indications for which there are no products with demonstrated analgesic efficacy, such as interstitial cystitis or chronic pancreatitis.

FDA's briefing documents list proposed safety protocols for further development from the three sponsors that have conducted trials of anti-NGF products -- Pfizer Inc. (NYSE:PFE), Johnson & Johnson (NYSE:JNJ) and Regeneron Pharmaceuticals Inc. (NASDAQ:REGN). All three proposed excluding or limiting concomitant NSAID use with anti-NGF treatment based on analyses by the companies showing a potential link between concomitant use and joint destruction. FDA will ask the panel whether data support allowing trials to proceed with some amount of concurrent NSAID use, as well as if NSAID use can be limited after approval. ...