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.
About ILARIS:
Ilaris acts by blocking the role of interleukin-1β (IL-1β), 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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