US FDA to seek panel's advice on 'complicated' matters with Novartis gouty arthritis drug
This article was originally published in Scrip
Executive Summary
While Novartis' Phase III trials of Ilaris (canakinumab) demonstrated statistically significant decreases in pain intensity versus triamcinolone and the risk of new flare ups in patients with gouty arthritis, the drug was associated with an increased risk of serious infections and neutropenia, elevations in uric acid and triglycerides and a possible decline in renal function, US FDA drug reviewers said in briefing documents released 17 June ahead of an advisory committee meeting.