FDA Approves Canakinumab for Adult Onset Still’s Disease
The US Food and Drug Administration (FDA) has approved canakinumab (Ilaris) injection for the treatment of active Still’s Disease, including adult-onset Still’s Disease (AOSD).
“Prior to today’s approval, patients had no FDA-approved treatments for their disease, which can include symptoms such as painful arthritis, fevers, and rash,” said Nikolay Nikolov, FDA’s Center for Drug Evaluation and Research, Rockville, Maryland. “Today’s approval provides patients with a treatment option.”
Characteristics of AOSD have considerable overlap with systemic juvenile idiopathic arthritis (SJIA), which includes fever, arthritis, rash, and elevated markers for inflammation. The overlapping features of AOSD and SJIA suggest this is a disease continuum rather than 2 separate diseases.
The role of interleukin-1 (IL-1) is well-established in AOSD and SJIA. Canakinumab works by blocking the effects of IL-1 and suppressing inflammation in patients with this autoinflammatory disorder.
The safety and efficacy of canakinumab 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.
Common side effects reported by patients treated with canakinumab are infections, abdominal pain, and injection-site reactions. The prescribing information for canakinumab includes a warning for potential increased risk of serious infections due to IL-1 blockade. Macrophage activation syndrome may develop in patients with rheumatic conditions and should be aggressively treated. Treatment with immunosuppressants may increase the risk of malignancies. Patients are advised not to receive live vaccinations during treatment.
SOURCE: US Food and Drug Administration