Novartis: positive opinion for Fabhalta in EU

(CercleFinance.com) - The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion on Fabhalta for the treatment of C3-deposited glomerulopathy, Novartis announced on Friday.


This decision paves the way for a marketing authorization from the European Commission within the next two months, the Swiss pharmaceutical company said.

If approved, this tablet would become the first drug approved for the treatment of this extremely rare kidney disease, for which there is currently no officially approved therapy.

Novartis says that this opinion is based on clinical data showing a reduction of over 35% in proteinuria and a stabilization of the estimated glomerular filtration rate (eGFR), a key indicator of kidney function.

C3-deposit glomerulopathy, generally diagnosed in young adults, results in kidney failure in half of all cases within ten years of diagnosis.

Already approved for the treatment of paroxysmal nocturnal hemoglobinuria (PNH), Fabhalta is currently under regulatory review for C3 glomerulopathy in the US, China and Japan.


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