US FDA advisory panel says no to Novartis gout drug Ilaris; agency backs safety of Shire's Firazyr

Swiss drug major Novartis (NOVN: VX) says that an advisory committee of the Food and Drug Administration yesterday voted 11 to one against recommending approval of the firm’s Ilaris (ACZ885; canakinumab) to treat gouty arthritis attacks, but in favor of the overall efficacy of the drug in patients who cannot obtain adequate relief with non-steroidal anti-inflammatory drugs (NSAIDs) or colchicine.

The panel also unanimously voted against the drug for delaying and reducing the frequency of future attacks. While most panelists said the drug was effective in company studies of gout patients, they also noted higher rates of serious infections and other potential side effects associated with Ilaris. Committee members raised the potential for use in a more narrow population of gouty arthritis patients.

Company will seek to identify appropriate patient population