Novartis gets FDA approval for Fabhalta in IgAN patients

TBE/iStock Editorial via Getty Images Novartis ( NYSE: NVS ) has received FDA accelerated approval for its drug Fabhalta to be used in the reduction of proteinuria in adults with primary immunoglobulin A nephropathy, or IgAN, at risk of rapid disease progression, according to the agency’s website . According to the product's expanded label, continued approval for the indication could be contingent on a confirmatory clinical trial. Fabhalta is already approved for the treatment of adults with paroxysmal nocturnal hemoglobinuria, or PNH.

The product was approved in December 2023 . Other approved drugs for IgAN include Travere Therapeutics’ ( TVTX ) Filspari and Calliditas Therapeutics’ ( CALT ) Tarpeyo. More on Novartis Novartis: Another Beat, Another Raise Why Novartis Deserves Your Attention After Q2 2024 Results Novartis AG (NVS) Q2 2024 Earnings Call Transcript Novartis sues FDA for approving Entresto generic Novartis' Scemblix granted FDA Priority Review status for front-line CML.