ADZYNMA (Takeda Pharmaceuticals Australia Pty Ltd)
Product name
ADZYNMA
Date registered
Evaluation commenced
Decision date
Approval time
190 (255 working days)
Active ingredients
apadamtase alfa, cinaxadamtase alfa
Registration type
NCE/NBE
Indication
ADZYNMA is a recombinant ADAMTS13 (rADAMTS13) enzyme replacement therapy (ERT) indicated for the treatment of ADAMTS13 deficiency in patients with congenital thrombotic thrombocytopenic purpura (cTTP).
ADZYNMA can be used for all age groups.
Registration process
Orphan drug
Sponsors receive a fee waiver to help bring medicines for a small population to market.