FDA Rejects Gout Pain Drug Application
by Zangani • 10 November 2011 • Pain News
Novartis was informed by the FDA that in order for the drug to be considered as a gout therapy in the future, further data in refractory patients will be needed. Although canakinumab showed efficacy in its clinical trials, specifically by reducing gout attacks and curbing pain, the FDA ultimately was troubled by what it believed to be an unacceptably high rate of serious infections (1.9%).