Fulranumab regulatory update

FDA's Arthritis Drugs Advisory Committee voted 21-0 that anti- nerve growth factor (NGF) agents should continue to be developed to treat osteoarthritis (OA) pain. Because the joint destruction was increased in patients taking anti-NGFs with NSAIDs, the panel felt studies in OA could continue if concomitant NSAID use is excluded and additional safeguards are put in place. These could include measuring biomarkers of joint destruction and increasing use of MRI. The panel did not feel anti-NGFs should be restricted to refractory OA patients despite an increase in joint destruction seen in clinical trials.

The panel also voted 20-1 that anti-NGFs should be studied in indications for which there are no products with demonstrated analgesic efficacy, such as interstitial cystitis or chronic pancreatitis. ...