Novartis’ Anti-Inflammatory Drug Ilaris Approved by US FDA: First Treatment for Adult Still’s Disease (AOSD)!

The U.S. Food and Drug Administration (FDA) recently approved Novartis’ anti-inflammatory drug Ilaris (Elater, generic name: canakimumab, kanazumab) for the treatment of active Still’s disease, including Adult paroxysmal Still’s disease (AOSD). Previously, Ilaris has been granted priority review designation (PRD) for the treatment of Still’s disease.

It is worth mentioning that Ilaris is the first drug approved for the treatment of Still’s disease. Previously, Ilaris was also approved for the treatment of patients with systemic juvenile idiopathic arthritis (SJIA) aged ≥ 2 years.

Nikolay Nikolov, MD, acting director of the Department of Rheumatology and Transplantation Medicine at the FDA Center for Drug Evaluation and Research, said: “Before today’s approval, there is no FDA-approved treatment for patients with Still’s disease, which manifests as painful arthritis, fever and rash And other symptoms. Today’s approval provides these patients with the first treatment option.”

Adult-Onset Still’s Disease (AOSD) is a rare and serious autoimmune disease of unknown etiology. Autoimmune diseases are caused by abnormalities of the immune system. Such abnormalities can trigger an inflammatory response, thereby damaging the body’s own tissues. The characteristics of AOSD have considerable overlap with systemic juvenile idiopathic arthritis (SJIA), including elevated fever, arthritis, rash, and inflammation markers. The overlapping features of AOSD and SJIA indicate that this is a disease continuum, rather than two separate diseases.

Interleukin-1 (IL-1) is an important cytokine that regulates the body’s immune system, and its role in AOSD and SJIA has been confirmed. Ilaris works by blocking the action of IL-1 and inhibiting inflammation in patients with this autoimmune disease. The safety and effectiveness of Ilaris in the treatment of AOSD are determined by comparable pharmacokinetic exposure, extrapolation of the established efficacy of Ilaris in the treatment of SJIA, and the safety of Ilaris in the treatment of AOSD and other diseases.

Among patients receiving Ilaris treatment, common side effects reported include infections (cold and upper respiratory tract infections), abdominal pain, and injection site reactions. Ilaris’ prescription information includes warnings that may increase the risk of serious infections due to IL-1 blockade. Macrophage activation syndrome (MAS) is a known life-threatening disease that may occur in rheumatic diseases, especially in patients with Still’s disease, and should be actively treated. Treatment with immunosuppressants may increase the risk of malignant tumors. During treatment, patients are advised not to receive live vaccination.