FDA approves first treatment for rare and serious adult Still’s disease
SPRING SILVER, Md., June 16, 2020 / PRNewswire / – The United States Food and Drug Administration today approved the injection of Ilaris (canakinumab) for the treatment of Active Still disease, including Adult Still’s disease ( MSAO). Ilaris has already been approved for juvenile systemic idiopathic arthritis (JIA) in patients 2 years of age and older.
“Prior to today’s approval, patients had no FDA-approved treatment for their disease, which can include symptoms such as painful arthritis, fever, and rash,” said Nikolai Nikolov, MD, Acting Director of the Division of Rheumatology and Transplant Medicine at the FDA’s Center for Drug Evaluation and Research. “Today’s approval gives patients a treatment option.”
OSD is a rare and serious autoinflammatory disease of unknown origin. Auto-inflammatory diseases are caused by abnormalities in the immune system, which trigger an inflammatory response that can damage the body’s own tissues. The features of AOSD overlap considerably with systemic juvenile idiopathic arthritis (JIA), which includes fever, arthritis, rash, and high markers of inflammation. The overlapping characteristics of AOSD and JIA suggest that it is a continuum of illnesses rather than two separate illnesses.
The role of interleukin-1 (IL-1), a type of cytokine important in regulating the body’s immune system, is well established in AOSD and JIA. Ilaris works by blocking the effects of IL-1 and suppressing inflammation in patients with this autoinflammatory disorder. The safety and efficacy of Ilaris for the treatment of patients with ASM have been established using comparable pharmacokinetic exposure and extrapolation of the established efficacy of canakinumab in patients with JIA, as well as the safety of canakinumab. in patients with MSA and other diseases.
Common side effects reported by patients treated with Ilaris are infections (colds and upper respiratory tract infections), abdominal pain and injection site reactions. Ilaris prescribing information includes a warning about a potential increased risk of serious infections due to IL-1 blockade. Macrophage activation syndrome (SAM) is a known life-threatening disorder that can develop in patients with rheumatic conditions, especially Still’s disease, and should be treated aggressively. Treatment with immunosuppressants may increase the risk of malignant tumors. Patients are advised not to receive live vaccines during treatment.
Ilaris got Priority review designation, under which the FDA’s goal is to respond to a request within six months when the agency determines that the drug, if approved, would significantly improve the safety or effectiveness of the treatment, diagnosis or prevention of serious illness.
Ilaris approval has been granted to Novartis Pharmaceuticals Corporation.
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SOURCE US Food and Drug Administration