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CHMP recommends Ilaris for periodic fever syndromes
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In Europe, the Committee for Medicinal Products for Human Use has recommended approval for Ilaris in patients with tumor necrosis factor-receptor associated periodic syndrome, hyperimmunoglobulin D syndrome/mevalonate kinase deficiency or familial Mediterranean fever, according to a press release.
“Few treatments exist for people with these potentially life-threatening conditions,” Paul Hudson, chief executive officer of Novartis Pharmaceuticals, said in the release. “Today’s positive recommendation is a great stride forward for patients who urgently need new treatment options.”
The recommendation by the Committee for Medicinal Products for Human Use (CHMP), which also recommended a new ready-for-injection 150-mg/ml solution, used results from the phase 3 CLUSTER study that demonstrated patients on Ilaris (canakinumab) — a monoclonal antibody inhibitor of interleukin-1 beta — had control of disease on day 15 and sustained this through week 16. These data were consistent for tumor necrosis factor-receptor associated periodic syndrome, hyperimmunoglobulin D syndrome/mevalonate kinase deficiency and familial Mediterranean fever.
The FDA made the same approval for the treatment in September and the European Commission — which also approved the drug for refractory acute gouty arthritis — approved the treatment for a license extension to treat patients with adult-onset Still’s disease in August. Both the FDA and European Commission have also approved Ilaris for systemic juvenile idiopathic arthritis. In addition, more than 70 countries have approved the treatment for cryopyrin-associated periodic syndromes.
“Novartis is committed to paving the way forward for rare diseases, especially through treatments like Ilaris which has the potential to raise the standard of care,” Hudson said. – by Will Offit
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