Novartis' Ilaris first drug approved for Still's disease

The US Food and Drug Administration has approved Novartis' Ilaris (canakinumab) as the first treatment for Active Still’s disease, including Adult-Onset Still’s Disease (AOSD), following a priority review.

AOSD is a rare and serious autoinflammatory disease of unknown origin, but with characteristics that have considerable overlap with Systemic Juvenile Idiopathic Arthritis (SJIA), such as fever, arthritis, rash and elevated markers for inflammation.

According to the FDA, the overlapping features of AOSD and SJIA, for which Ilaris is already approved, suggest this is a disease continuum rather than two separate diseases.

The role of interleukin-1 (IL-1), a type of cytokine important in regulating the body’s immune system, is well-established in AOSD and SJIA.

Ilaris works by blocking the effects of IL-1 and suppressing inflammation in patients with this autoinflammatory disorder.

On the safety side, common side effects reported by patients treated with Ilaris are infections (colds and upper respiratory tract infections), abdominal pain and injection-site reactions, and the drug's information includes a warning for potential increased risk of serious infections due to IL-1 blockade.

17th June 2020

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