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TAKHZYRO (Shire Australia Pty Ltd)
Product name
TAKHZYRO
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
147 working days (255)
Active ingredients
lanadelumab
Registration type
NCE/NBE
Indication
TAKHZYRO is indicated for routine prevention of recurrent attacks of hereditary angioedema (C1-esterase-inhibitor deficiency or dysfunction) in patients aged 12 years 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.