On August 25, the U.S. Food and Drug Administration (FDA) approved the interleukin-1 inhibitor canakinumab (Ilaris) for the treatment of patients with gout. However, neither the FDA nor the drug’s manufacturer, Novartis, released statements announcing the approval, according to a report from MedPage Today. Initially, when Novartis sought approval for canakinumab for a gouty arthritis indication in 2011, the FDA cited concerns of insufficient safety and disease modification data in its rejection. Since then, only a few studies have focused on the agent and have shown that patients have achieved minimal improvements in their disease severity when receiving the drug—while experiencing increased rates of serious adverse events. The new approval specified that canakinumab may be used for gout flares in patients who did not respond to or were contraindicated for colchicine, nonsteroidal anti-inflammatory drugs, and corticosteroids. Experts stressed that despite the approval, a single dose of the agent is expected to cost $18,000 and may not be covered by insurance—making it inaccessible to most patients.
September 14, 2023