Novartis has received the US Food and Drug Administration's (FDA) approval for Ilaris (canakinumab) to treat rare Periodic Fever Syndrome conditions.
Periodic Fever Syndromes are a group of diseases that cause serious recurrent fever and pathogenic inflammation through non-infectious activation of the immune system.
Ilaris inhibits Interleukin-1 (IL-1) beta, which is an important part of the body's immune system defences. Excessive production of IL-1 beta causes certain inflammatory diseases.
This human monoclonal antibody hampers IL-1 beta's activity for a sustained period of time, therefore inhibiting inflammation that is caused by its over-production.
Ilaris is used to treat three rare and distinct types of Periodic Fever Syndromes such as Tumour Necrosis Factor-Receptor Associated Periodic Syndrome (TRAPS), Hyperimmunoglobulin D Syndrome (HIDS) / Mevalonate Kinase Deficiency (MKD) and Familial Mediterranean Fever (FMF).
Novartis Pharmaceuticals CEO Paul Hudson said: "Gaining three simultaneous 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 latest FDA approvals are based on results from the Phase III CLUSTER study of patients with TRAPS, HIDS / MKD or FMF for 16 weeks.
Ilaris is already approved in the US to treat Cryopyrin-Associated Periodic Syndromes (CAPS) and Systemic Juvenile Idiopathic Arthritis (SJIA).
In August this year, the European Commission approved Ilaris for the treatment of Adult-Onset Still's Disease (AOSD).
