Posted by Michael Wonder on 17 Dec 2020
Novartis investigational oral therapy iptacopan (LNP023) receives FDA breakthrough therapy designation for PNH and rare paediatric disease designation for C3G
16 December 2020 - Iptacopan is in development for paroxysmal nocturnal haemoglobinuria, as well as C3 glomerulopathy and several other rare renal diseases including IgA nephropathy, atypical hemolytic uremic syndrome and membranous nephropathy; first FDA filings anticipated in 2023.
Novartis today announced that the U.S. FDA granted iptacopan (LNP023) breakthrough therapy designation in paroxysmal nocturnal haemoglobinuria and rare paediatric disease designation in C3 glomerulopathy.
