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Novartis' Ilaris wins three new FDA approvals

Immunotherapeutic expands in rare Periodic Fever Syndrome conditions

Novartis' anti-inflammatory therapy Ilaris (canakinumab) has received new US approvals for its use in three rare Periodic Fever Syndrome conditions.

Its label now includes Tumor Necrosis Factor-Receptor Associated Periodic Syndrome (TARPS), Hyperimmunoglobulin D Syndrome/Mevalonate Kinase Deficiency (HIDS/MKD), and Familial Mediterranean Fever (FMF).

The decision was based on results from the phase III CLUSTER study, which showed rapid and sustained disease control in patients treated with the interleukin-1 beta inhibitor over the course of 16 weeks.

Paul Hudson, Novartis Pharmaceuticals' chief executive, said: “Gaining three FDA approvals of Ilaris is a momentous turning point for people who suffer with these severe, debilitating diseases.

“There is a significant unmet need in these conditions, particularly in children, and Novartis is proud to provide a new treatment option to those who so desperately need it.”

The three new indications add to Ilaris' existing approvals in Adult-Onset Still's Disease (AOSD), gouty arthritis, and autoinflammatory condition Systemic Juvenile Idiopathic Arthritis (SJIA), the most aggressive form of juvenile arthritis.

The biologic was first approved in both the US and EU in 2009 for the treatment of rare genetic disorder Cryopyrin-Associated Periodic Syndromes (CAPS), which is believed to occur in around 2,500 people in Europe - though many are still thought to be undiagnosed.

Periodic Fever Syndromes cause disabling and recurrent fevers that are often accompanied by joint pain, muscle pain, skin rashes and swelling, with most patients presenting symptoms in early childhood. 

Article by
Rebecca Clifford

27th September 2016

From: Regulatory



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