FDA Approves Ilaris for Rare Juvenile Arthritis

May 10, 2013

The US Food and Drug Administration (FDA) has approved canakinumab (Ilaris, Novartis) to treat active systemic juvenile idiopathic arthritis (JIA) in patients aged 2 years and older, the manufacturer announced today.

The drug, administered monthly by subcutaneous injection, is the first interleukin-1-beta inhibitor approved for this rare and disabling form of childhood arthritis, according to a press release from the manufacturer. Children with systemic JIA experience rapid onset of high daily fever, rash, high levels of inflammatory markers, and destructive arthritis.

Some experts describe canakinumab as a more benign alternative to the corticosteroids often prescribed for systemic JIA. Impaired growth and osteoporosis are some of the adverse events associated with corticosteroids.

Canakinumab is already approved to treat cryopyrin-associated periodic syndromes, including Familial Cold Autoinflammatory Syndrome and Muckle-Wells Syndrome. The drug's label warns that canakinumab may weaken the body's immune response to infections, increasing the risk for serious infection. Accordingly, clinicians should exercise caution when administering canakinumab to patients with infections, a history of recurring infections, or underlying conditions that may predispose them to infections. The FDA also advises that canakinumab should not be given concurrently with live vaccines.

Last month, the FDA approved another anti-interleukin agent, tocilizumab (Actemra, Genentech), to treat polyarticular JIA in patients aged 2 years and older with active disease. Tocilizumab is an interleukin 6 receptor blocker. Tocilizumab was approved for systemic JIA in April 2011.