TAKHZYRO (Takeda Pharmaceuticals Australia Pty Ltd)
Product name
TAKHZYRO
Date registered
Evaluation commenced
Decision date
Approval time
221 (255 working days)
Active ingredients
lanadelumab
Registration type
EOI
Indication
TAKHZYRO is indicated for routine prevention of recurrent attacks of hereditary angioedema (C1-esterase-inhibitor deficiency or dysfunction) in patients aged 2 years and older.
Registration process
Orphan drug
Sponsors receive a fee waiver to help bring medicines for a small population to market.