Game-changer for kidney disease: Novartis’ Fabhalta wins FDA approval in record time

Game-changer for kidney disease: Novartis’ Fabhalta wins FDA approval in record time

Novartis has reached a pivotal moment in the treatment of rare kidney diseases with the US Food and Drug Administration (FDA) granting accelerated approval for Fabhalta (iptacopan), a novel therapy designed to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN). This rare, progressively debilitating condition affects the kidneys by attacking the glomeruli, the […]

Sobi and Apellis Pharmaceuticals report promising results for pegcetacoplan in phase 2 NOBLE study

Sobi and Apellis Pharmaceuticals report promising results for pegcetacoplan in phase 2 NOBLE study

Sobi and Apellis Pharmaceuticals, Inc. have announced encouraging one-year outcomes from the phase 2 NOBLE study, investigating the efficacy of systemic pegcetacoplan for treating post-transplant recurrence of C3 glomerulopathy (C3G) and primary immune complex membranoproliferative glomerulonephritis (IC-MPGN). These findings were presented at the European Renal Association (ERA) Congress, held from May 23-26 in Stockholm, Sweden. […]

Apellis reports positive results for pegcetacoplan in phase 2 C3G trial

Apellis reports positive results for pegcetacoplan in phase 2 C3G trial

Apellis Pharmaceuticals has reported positive results for pegcetacoplan from the phase 2 DISCOVERY clinical trial in patients with C3 glomerulopathy (C3G), a type of kidney disease. According to the US biopharma company, the 48-week results demonstrated that patients subjected to pegcetacoplan had sustained improvements across key clinical measures. These include a greater than 65% mean […]