FDA Approves Expanded Use for Biologic Autoinflammatory Disease Drug


Ilaris is the first FDA-approved biologic treatment for Tumor Necrosis Factor–Receptor Associated Periodic Syndrome, Hyperimmunoglobulin D Syndrome/Mevalonate Kinase Deficiency and Familial Mediterranean Fever.

Novartis has received 3 FDA approvals for the expanded use of Ilaris, also known as canakinumab, to treat distinct types of Periodic Fever Syndromes. Periodic Fever Syndromes are a group of rare autoinflammatory diseases that cause disabling and persistent fevers. They are accompanied by joint pain, swelling, muscle pain, and skin rashes with potentially life-threatening complications in some patients.

Ilaris is the first FDA-approved biologic treatment for Tumor Necrosis Factor—Receptor Associated Periodic Syndrome (TRAPS), Hyperimmunoglobulin D Syndrome (HIDS)/Mevalonate Kinase Deficiency (MKD) and Familial Mediterranean Fever (FMF).

Ilaris is a selective, high-affinity, human monoclonal antibody that inhibits the Interleukin-1 beta in the body, which is critical to the body’s immune system defense. When the body excessively produces IL-1 beta in the body, it can contribute to certain inflammatory diseases.

“Gaining 3 simultaneous FDA approvals of Ilaris is a momentous turning point for people who suffer with these severe, debilitating diseases,” said Paul Hudson, CEO of Novartis, in a press release. “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 FDA based its approval on results from the phase 3 CLUSTER study, which showed rapid and sustained disease control in patients who took Ilaris compared to a placebo. These results came after examining patients with TRAPS, HIDS/MKD or FMF through 16 weeks.

In clinical trials, the most common adverse effects linked to Ilaris were infections in the upper respiratory tract, some of which were serious.

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