Novartis' Anti-inflammatory Drug Ilaris Receives FDA Approval as First Treatment for Adult-Onset Still's Disease (AOSD)

June 17, 2020 /BioValleyBIOON/ -- U.S. Food and Drug Administration (FDA) recently approvedNovartisNovartis’ anti-inflammatory drug Ilaris (Yilaili; generic name: canakinumab), indicated for the treatment of active Still’s disease, including adult-onset Still’s disease (AOSD). Previously, Ilaris had been granted Priority Review designation (PRD) for the treatment of Still’s disease.

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

Nikolay Nikolov, M.D., Acting Director of the Division of Rheumatology and Transplant Medicine in the FDA’s Center for Drug Evaluation and Research, stated: “Prior to today’s approval, patients with Still’s disease had noFDAapproved treatment for this condition, which presents with symptoms including painful arthritis, fever, and rash. Today’s approval provides the first treatment option for these patients.”

Adult-Onset Still's Disease (AOSD) is a rare and severeAutoimmunitySexual disorder, etiology unknown.AutoimmunityAutoinflammatory diseases are caused by abnormalities in the immune system, which trigger inflammatory responses and thereby damage the body’s own tissues. The features of Adult-Onset Still’s Disease (AOSD) overlap considerably with those of Systemic Juvenile Idiopathic Arthritis (SJIA), including fever, arthritis, rash, and elevated inflammatory markers. The overlapping features of AOSD and SJIA suggest that they represent a disease continuum rather than two distinct entities.

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 thisAutoimmunityinflammatory conditions. The safety and efficacy of Ilaris in the treatment of AOSD are established through comparable pharmacokinetic exposure, extrapolation from the established efficacy of Ilaris in the treatment of SJIA, and the safety profile of Ilaris in the treatment of AOSD and other diseases.

Among patients receiving Ilaris therapy, commonly reported adverse effects include infections (such as the common cold and upper respiratory tract infections), abdominal pain, and injection site reactions. The prescribing information for Ilaris includes a warning that IL-1 blockade may increase the risk of serious infections. Macrophage activation syndrome (MAS) is a known life-threatening condition that can occur in patients with rheumatic diseases, particularly those with Still’s disease, and should be treated aggressively. Treatment with immunosuppressants may increase the risk of malignancy.Tumorrisk. During treatment, patients are advised not to receive live vaccines.(Bioon.com)

Original Source:FDA approves First Treatment for Adult Onset Still's Disease, a Severe and Rare Disease