Ilaris, administered as an injection, works by targeting the inflammatory cytokine interleukin-1beta, or IL-1. The proposed indication was for treating gouty arthritis attacks in people who do not respond to NSAIDs or colchicine, as well as extending the time to the next attack and reducing the frequency of attacks.

John Sundy, MD, a rheumatologist at Duke University Medical Center in Durham, N.C. – and a medical consultant for Novartis – says the standard approach to treating gout attacks won’t likely change even if Ilaris is eventually approved.

“If what people are using is working for them just fine, [they] don’t [need to] switch. But it [would be] great to have this option,” Dr. Sundy explains. “I think most people will remain with NSAIDs to treat their gout attacks. One, they are very effective, and two, they are very inexpensive.”

The Arthritis Advisory Committee reviewed two studies of more than 450 gout patients taking 150 milligrams of Ilaris over six months. The drug was found to be effective at reducing both the pain and the recurrence of gout flares, but it also came with a greater risk of serious infections than the comparison drug, the corticosteroid triamcinolone, and with a potential for kidney damage.

"Many members of the FDA panel recognized and said that there is still an unmet need in the treatment of acute gouty arthritis, but I think it was clear committee members had concerns with the proposed indications for use of this agent in the current application," explains Lawrence Edwards, MD, a professor of medicine in the division of rheumatology at the University of Florida School of Medicine in Gainesville and a member of the Novartis presentation group at Tuesday's meeting.

In a written statement posted on the company’s website, the global head of development at Novartis Pharmaceuticals, Trevor Mundel, MD, said, “We continue to believe in the benefits of [Ilaris] for this painful and debilitating disease and will work closely with the FDA to identify the right patient population who will benefit from this therapy."