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Novartis Gets CHMP Opinion for Label Expansion of Fabhalta
Novartis announced that the CHMP has given a positive opinion for the label expansion of Fabhalta to treat C3 glomerulopathy (C3G), an ultra-rare kidney disease. A final decision from the European Commission is expected in two months. This decision is supported by the APPEAR-C3G study, showing Fabhalta’s significant reduction in proteinuria in C3G patients.