SILVER SPRING
Fabhalta traditional approval for primary IgAN
- Sponsor
- Novartis $NVS
- Drug
- Fabhalta · iptacopan
- Indication
- primary immunoglobulin A nephropathy
FDA grants traditional approval to Novartis's Fabhalta (iptacopan) to slow kidney function decline in adults with primary immunoglobulin A nephropathy.
What this means
Fabhalta is an oral pill that blocks part of the immune system to reduce kidney damage in adults with a disease called IgA nephropathy. The FDA converted its previous accelerated approval to a full, traditional approval based on confirmatory trial data. The agency now recommends Fabhalta "for the treatment of adults with primary immunoglobulin A nephropathy at risk of rapid disease progression.