On Friday, the U.S. Food and Drug Administration (FDA) granted traditional approval for Novartis AG’s (NYSE:NVS) oral medication, Fabhalta (iptacopan).
The treatment is authorized to slow the decline of kidney function in adult patients suffering from primary immunoglobulin A nephropathy (IgAN) who face a high risk of disease progression.
Because IgAN can progress to kidney failure requiring dialysis or a transplant, slowing kidney function decline with Fabhalta could help delay the need for those interventions in at-risk patients.
Fabhalta, recognized as a first-in-class complement inhibitor, secured this traditional approval following a priority review.
It previously obtained accelerated FDA approval in August 2024 for reducing proteinuria in primary IgAN patients.
