June 16, 2020

The U.S. FDA has approved an expanded indication for Ilaris® (canakinumab), manufactured by Novartis. The product is now indicated to treat active Still’s disease, including adult-onset Still’s disease (AOSD), in patients two years of age and up. Ilaris was previously approved to treat Still’s disease only in the form of systemic juvenile idiopathic arthritis (SJIA).

A chronic autoimmune disorder, Still’s disease is characterized by high intermittent fevers, joint and muscle pain, joint inflammation, skin rash, swollen lymph glands, enlarged spleen and liver, and inflammation around the heart and lungs. Patients may also develop anemia and have abnormally high white blood cell counts. An interleukin-1β blocker, Ilaris works by reducing the immune system’s inflammatory activity.

Approval for the expanded indication is based on the established efficacy of Ilaris in patients diagnosed with SJIA, as well as a placebo-controlled study in which efficacy data for AOSD was generally consistent with the results of efficacy analysis in SJIA patients.

Recommended dosing under the Still’s disease indication is 4mg/kg of patient’s body weight, up to a maximum of 300mg, in patients who weigh at least 7.5kg (16.5 pounds). Ilaris should be administered via subcutaneous injection once every four weeks.

Originally approved in 2009, Ilaris is also indicated to treat periodic fever syndromes.

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