DESIGNATION OF canakinumab (ILARIS) AS AN ORPHAN DRUG
I, Dr Anthony Gill, Delegate of the Secretary for the purposes of 16J of the Therapeutic Goods Regulations 1990 (“the Regulations”), acting under subregulation 16J (2) of the Regulations, designate canakinumab (ILARIS) as an orphan drug on the 12 November 2012 for the treatment of Cryopyrin Associated Periodic Syndromes (CAPS) in adults and children aged 2 years and older including:
- Muckle-Wells Syndrome (MWS)
- Familial Cold-induced Auto inflammatory Syndrome (FCAS)/Familial Cold Urticaria (FCU)
- Neonatal-Onset Multisystem Inflammatory Disease (NOMID)/Chronic Infantile Neurological Cutaneous and Articular syndrome (CINCA)
The dose form of canakinumab (ILARIS) for this indication is Powder for Injection.
The sponsor of canakinumab (ILARIS) is Novartis Pharmaceuticals Australia Pty Limited.
(Signed by)
Dr Anthony Gill
Delegate of the Secretary
12 November 2012