FDA approves Novartis’ Fabhalta for additional indication

The FDA has approved Novartis’ Fabhalta for the reduction of proteinuria in adults with primary immunoglobulin A nephropathy, or IgAN, at risk of rapid disease progression. “This indication is approved under accelerated approval based on reduction of proteinuria. It has not been established whether FABHALTA slows kidney function decline in patients with IgAN. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory clinical trial,” according to updated prescribing information posted to the agency’s website.