View all newsletters
Receive our newsletter - data, insights and analysis delivered to you
September 25, 2016

US FDA grants approval for Novartis’ Ilaris to treat Periodic Fever Syndromes

Novartis has received the US Food and Drug Administration's (FDA) approval for Ilaris (canakinumab) to treat rare Periodic Fever Syndrome conditions.

By Srivari Aishwarya

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.

"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."

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).

Related Companies

NEWSLETTER Sign up Tick the boxes of the newsletters you would like to receive. A weekly roundup of the latest news and analysis, sent every Friday. The pharmaceutical industry's most comprehensive news and information delivered every month.
I consent to GlobalData UK Limited collecting my details provided via this form in accordance with the Privacy Policy
SUBSCRIBED

THANK YOU

Thank you for subscribing to Pharmaceutical Technology