FABHALTA Novartis Pharmaceuticals Australia Pty Ltd
Product name
FABHALTA
Accepted date
Apr-2025
Active ingredients
iptacopan
Proposed indication
FABHALTA (iptacopan) treats adult patients with:
1. Paroxysmal nocturnal haemoglobinuria - where the immune system mistakenly attacks and destroys red blood cells, which leads to anemia and;
2. Complement 3 glomerulopathy - caused by an abnormally active complement system (part of the immune system) which leads to impaired kidney function.
1. Paroxysmal nocturnal haemoglobinuria - where the immune system mistakenly attacks and destroys red blood cells, which leads to anemia and;
2. Complement 3 glomerulopathy - caused by an abnormally active complement system (part of the immune system) which leads to impaired kidney function.
Application type
C (new indication)
Publication date
Apr-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.