AMVUTTRA (Medison Pharma Australia Pty Ltd)
Product name
AMVUTTRA
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
118 (120 working days)
Active ingredients
vutrisiran sodium
Registration type
EOI
Indication
Amvuttra is indicated for the treatment of hereditary transthyretin amyloidosis in adult patients with stage 1 or stage 2 polyneuropathy (hATTR-PN).
Amvuttra is indicated for the treatment of wild-type or hereditary transthyretin amyloidosis in adult patients with cardiomyopathy (ATTR-CM).
Registration process
Orphan drug
Sponsors receive a fee waiver to help bring medicines for a small population to market.