FDA Approves Novartis' Oral Fabhalta For Treatment Of Adults With Complement 3 Glomerulopathy

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(RTTNews) - Novartis AG (NVS) announced that the U.S. Food and Drug Administration has approved oral Fabhalta (iptacopan) for the treatment of adults with complement 3 glomerulopathy to reduce proteinuria. This makes it the first and only treatment approved for this condition.

Before the approval of Fabhalta, patients had to rely on supportive care, broad immunosuppression, and symptom management.

C3 glomerulopathy is a progressive and ultra-rare kidney disease that, until now, has had no approved treatments. The average age of diagnosis is around 23 years old. Prognosis is poor, with approximately half of people living with C3G progressing to kidney failure within 10 years of diagnosis, requiring lifelong dialysis and/or kidney transplantation. People living with C3G may experience high levels of fatigue, mobility issues affecting everyday life activities, and mental health symptoms, including depression and anxiety.

Last month, Fabhalta received a positive CHMP Opinion in C3G by the European Medicines Agency (EMA). Regulatory reviews for this indication are ongoing in China and Japan. Fabhalta received its first FDA approval in December 2023 for the treatment of adults with paroxysmal nocturnal hemoglobinuria or PNH. Discovered by Novartis, Fabhalta is also being studied in a broad range of other rare kidney diseases, including atypical hemolytic uremic syndrome (aHUS), immune complex membranoproliferative glomerulonephritis (IC-MPGN) and lupus nephritis (LN). Studies are ongoing to evaluate the safety and efficacy profiles in these investigational indications.

In addition to Fabhalta, Novartis is advancing the late-stage development of two additional IgAN therapies with highly differentiated mechanisms of action: atrasentan, an investigational oral endothelin A receptor antagonist that received FDA filing acceptance in the second-quarter 2024 with a decision anticipated in the first-half of 2025, and zigakibart, an investigational subcutaneously administered anti-APRIL monoclonal antibody that is currently in Phase III development.

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