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NIKTIMVO Specialised Therapeutics Alim Pty Ltd
Product name
NIKTIMVO
Accepted date
Jul-2025
Active ingredients
axatilimab
Proposed indication
Niktimvo (axatilimab) is for the treatment of adults and patients 6 years and older with chronic graft-versus-host disease (cGVHD) who have already received at least two type of therapy. cGVHD may occur when donor immune cells attack the patient’s body after a stem cell or bone marrow transplant.
Application type
A (new medicine)
Publication date
Jul-2025
Orphan drug
Sponsors receive a fee waiver to help bring medicines for a small population to market.
Priority review
Involves faster TGA evaluation of vital and life-saving medicines for which a complete data dossier is available.