NIKTIMVO (Specialised Therapeutics Alim Pty Ltd)
Product name
NIKTIMVO
Date registered
Evaluation commenced
Decision date
Approval time
137 (255 working days)
Active ingredients
axatilimab
Registration type
NCE/NBE
Indication
Axatilimab is indicated for the treatment of chronic graft-versus host disease (cGVHD) after failure of at least two prior lines of systemic therapy in adult and paediatric patients 6 years and older weighing at least 40 kg.
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.