Novartis gets third FDA approval for oral Fabhalta

The company states: “Novartis (NVS) announced that oral Fabhalta, iptacopan, has received U.S. Food and Drug Administration approval for the treatment of adults with C3 glomerulopathy, to reduce proteinuria, making it the first and only treatment approved for this condition. Fabhalta is the only oral inhibitor of the alternative complement pathway to selectively target what is thought to be the underlying cause of the disease. Before the approval of Fabhalta, patients had to rely on supportive care, broad immunosuppression, and symptom management. The pivotal Phase III APPEAR-C3G study evaluated the efficacy and safety of twice-daily oral Fabhalta in adult patients with C3G1,10. The study was comprised of a 6-month randomized, double-blind treatment period with Fabhalta compared to placebo in addition to supportive care, followed by an additional 6-month open-label treatment period where all participants received Fabhalta.”