FDA Approves Expanded Use Of Novartis' Rare Disease Drug Fabhalta For Kidney Disease
Portfolio Pulse from Vandana Singh
The FDA has granted accelerated approval to Novartis AG's (NYSE:NVS) Fabhalta for the treatment of proteinuria in adults with primary immunoglobulin A nephropathy (IgAN). This approval is based on interim results from the Phase 3 APPLAUSE-IgAN study, showing a significant reduction in proteinuria. Continued approval will depend on further clinical benefit verification. Novartis is also developing two additional IgAN therapies.
August 08, 2024 | 1:52 pm
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The FDA has granted accelerated approval to Novartis' Fabhalta for treating proteinuria in IgAN patients. Interim Phase 3 results show a significant reduction in proteinuria, but continued approval will depend on further clinical benefit verification. Novartis is also advancing two additional IgAN therapies.
The FDA's accelerated approval of Fabhalta is a positive development for Novartis, as it demonstrates the drug's potential efficacy in reducing proteinuria in IgAN patients. The significant reduction in proteinuria observed in the interim Phase 3 results is a strong indicator of the drug's effectiveness. However, the continued approval is contingent on further clinical benefit verification, which introduces some uncertainty. Additionally, Novartis' advancement of two other IgAN therapies indicates a strong pipeline in this therapeutic area.
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