The government is now operating in accordance with the Guidance on Caretaker Conventions, pending the outcome of the 2025 federal election.
ONPATTRO (Alnylam Australia Pty Ltd)
Product name
ONPATTRO
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
157 (255 working days)
Active ingredients
patisiran
Registration type
NCE/NBE
Indication
ONPATTRO is indicated for the treatment of hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis) in adult patients with stage 1 or stage 2 polyneuropathy.