EVRYSDI (Roche Products Pty Ltd)
Product name
EVRYSDI
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
145 (255 working days)
Active ingredients
risdiplam
Registration type
NCE/NBE
Indication
EVRYSDI (powder for oral solution) is indicated for the treatment of 5q spinal muscular atrophy (SMA) in patients aged 2 months and older.
Registration process
Priority review
Involves faster TGA evaluation of vital and life-saving medicines for which a complete data dossier is available
Orphan drug
Sponsors receive a fee waiver to help bring medicines for a small population to market.