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FDA Approves Expanded Indications for Ilaris

FDA news release; 2016 Sep 23

Publish date:: October 17, 2016

The US Food and Drug Administration (FDA) has approved 3 new indications for Ilaris (canakinumab). Ilaris is manufactured and distributed by Novartis Pharmaceuticals Corporation, East Hanover, NJ.

Indications: Ilaris is an interleukin-1β blocker. The new indications are for rare and serious auto-inflammatory diseases in adult and pediatric patients:

Tumor necrosis factor receptor associated periodic syndrome (TRAPS),
Hyperimmunoglobulin D syndrome (HIDS)/mevalonate Kinase deficiency (MKD), and
Familial Mediterranean fever (FMF).

There are no previously approved therapies for TRAPS or HIDS/MKD.

Dosage/administration: Ilaris is administered by subcutaneous injection. Dosage is based on disease state and body weight. Additional information can be found at: https://www.pharma.us.novartis.com/sites/www.pharma.us.novartis.com/files/ilaris.pdf

Adverse reactions: TRAPS, HIDS/MKD, and FMF: The most common adverse reactions greater than 10% reported by patients treated with Ilaris are injection site reactions and nasopharyngitis.

Citation:

US Food and Drug Administration. FDA approves expanded indications for Ilaris for three rare diseases. FDA web site. September 23, 2016. http://www.fda.gov/newsevents/newsroom/pressannouncements/UCM522283.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery. Accessed October 6, 2016.

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