FDA OKs first treatment for adult onset Still’s disease

June 16, 2020

The U.S. Food and Drug Administration approved  Novartis Pharmaceuticals' 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.

Active Still’s disease, which includes symptoms such as painful arthritis, fevers and rash, had previously no treatment option. AOSD is a rare and serious autoinflammatory disease of unknown origin. Autoinflammatory diseases are caused by abnormalities of the immune system, which trigger an inflammatory response that can damage the body's own tissues. Characteristics of AOSD have considerable overlap with Systemic Juvenile Idiopathic Arthritis (SJIA), which includes fever, arthritis, rash and elevated markers for inflammation. According to the FDA, the overlapping features of AOSD and SJIA suggest this is a disease continuum rather than two separate diseases.

Ilaris works by blocking the effects of IL-1,  a type of cytokine important in regulating the body’s immune system, and suppressing inflammation in patients with this autoinflammatory disorder. The safety and efficacy of Ilaris for the treatment of patients with AOSD was established using comparable pharmacokinetic exposure and extrapolation of established efficacy of canakinumab in patients with SJIA, as well as the safety of canakinumab in patients with AOSD and other diseases.

Ilaris was granted Priority Review designation, under which the FDA’s goal is to take action on an application within six months where the agency determines that the drug, if approved, would significantly improve the safety or effectiveness of treating, diagnosing or preventing a serious condition.

Read the FDA release