US FDA rejects Novartis gouty arthritis drug; seeks more safety data
This article was originally published in Scrip
Executive Summary
The US FDA took the advice of a June advisory panel to reject Novartis interleukin-1 betablocker canakinumab (ACZ885) as a treatment for gouty arthritis until the company can provide more data supporting the drug's benefit-risk profile in refractory patients.