COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
DESIGNATION OF Nusinersen 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 Nusinersen as an orphan drug on 21 April 2016 for the treatment of Spinal Muscular Atrophy (SMA).
The dose form of Nusinersen for this indication is Solution for injection (intrathecal injection).
The sponsor of Nusinersen is Biogen Australia Pty Ltd.
(Signed by)
Dr Anthony Gill
Delegate of the Secretary
21 April 2016