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Novartis Ilaris to be the first FDA approved treatment for Adult-Onset Still’s Disease (AOSD)

Novartis has received the US FDA approval of expansion for Ilaris (canakinumab) for the treatment of Adult-Onset Still’s Disease (AOSD) as a subcutaneous injection.

Ilaris is the first US FDA approved treatment for AOSD.

The US FDA approval based on the extrapolation of a well-established safety and efficacy study of Ilaris in SJIA to AOSD, along with a supportive placebo-controlled trial in 36 AOSD patients.

The most common adverse events include infections, abdominal pain, and injection-site reactions. The label comes with a warning for increased risk of serious infections, and live vaccines should not be given simultaneously with Ilaris.

AOSD is an orphan indication affecting less than 1 case per 100,000 in the US. The drug has earlier received priority review designation for AOSD.


Ilaris acts by blocking the role of interleukin-1β (IL-), therefore suppressing inflammation in patients with this autoinflammatory disorder.

It was previously approved for the treatment of:

  • Active Systemic Juvenile Idiopathic Arthritis (SJIA) in patients 2 years of age

  • Periodic Fever Syndrome

  • Cryopyrin-Associated Periodic Syndromes

  • Tumour Necrosis Factor Receptor Associated Periodic Syndrome

  • Hyperimmunoglobulin D Syndrome//Mevalonate Kinase Deficiency in adult and pediatric patients

  • Familial Mediterranean Fever

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