FDA approves Ilaris injection for active, adult-onset Still's disease
The FDA has approved Novartis’ Ilaris injection for the treatment of active and adult-onset Still’s disease, according to a press release.
“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,” Nikolay Nikolov, MD, acting director of the Division of Rheumatology and Transplant Medicine at the FDA Center for Drug Evaluation and Research, said in the release. “Today’s approval provides patients with a treatment option.”
Ilaris (canakinumab), an IL-1 inhibitor, had previously been approved for systemic juvenile idiopathic arthritis in patients aged 2 years and older. According to the FDA, adult-onset Still’s disease shares “considerable overlap” with systemic JIA, as both are characterized by fever, arthritis, rash and elevated markers for inflammation. These shared characteristics suggest a disease continuum rather than two separate conditions, the release states.
The FDA based its approval for this indication on established comparable pharmacokinetic exposure and extrapolation of efficacy data among patients with systemic JIA, as well as safety data in those with adult-onset Still’s disease and other conditions.
According to the FDA, common adverse events reported by patients treated with Ilaris include infections — such as colds and upper respiratory tract infections — as well as abdominal pain and infection-site reactions. The prescribing information also includes a warning for a potential increased risk for serious infections due to IL-1 blockade.
“Macrophage activation syndrome (MAS) is a known, life-threatening disorder that may develop in patients with rheumatic conditions, in particular Still’s disease, and should be aggressively treated,” noted the FDA release. “Treatment with immunosuppressants may increase the risk of malignancies. Patients are advised not to receive live vaccinations during treatment.”
The FDA’s approval came after the agency had granted the drug its “priority review” designation. According to the FDA, the goal of this designation is to “take action on an application within six months where the agency determines that the drug, if approved, would significantly improve the safety or effectiveness of treating, diagnosing or preventing a serious condition.”
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