FDA Approves First Treatment for Adult Onset Still’s Disease, a Severe and Rare Disease | FDA

FDA Approves First Treatment for Adult Onset Still’s Disease, a Severe and Rare Disease | FDA



FDA Approves First Treatment for Adult Onset Still’s Disease, a Severe and Rare Disease

The U.S. Food and Drug Administration today approved Ilaris (canakinumab) injection for the treatment of Active Still’s disease, including Adult-Onset Still’s Disease (AOSD). Ilaris was previously approved for Systemic Juvenile Idiopathic Arthritis (SJIA) in patients aged 2 years and older.

Common side effects reported by patients treated with Ilaris are infections (colds and upper respiratory tract infections), abdominal pain and injection-site reactions. The prescribing information for Ilaris includes a warning for potential increased risk of serious infections due to IL-1 blockade. Macrophage activation syndrome (MAS) is a known, life-threatening disorder that may develop in patients with rheumatic conditions, in particular Still’s disease, and should be aggressively treated. Treatment with immunosuppressants may increase the risk of malignancies. Patients are advised not to receive live vaccinations during treatment.