Novartis's first complement factor B inhibitor iptacopan has been certified by the British Innovation Passport

Novartis recently announced that the British Medicines and Healthcare Products Regulatory Agency (MHRA), the National Institute of Health and Clinical Optimization (NICE), and the Scottish Medical Federation (SMC) have awarded oral therapy iptacopan (LNP023) for the treatment of C3 glomeruli "Innovation Passport" qualification for disease (C3G)

C3G is an extremely rare and severe form of primary glomerulonephritis, characterized by a disorder of complement regulation

Iptacopan is a pioneering oral factor B inhibitor discovered by the Novartis Institute of Biomedical Research.

The Innovation Passport is a pass to the Innovation Permit and Access (ILAP)

iptacopan is a first-in-class, oral, potent, selective, small molecule, and reversible factor B inhibitor.

Currently, iptacopan is being developed to treat many complement-driven renal diseases (CDRD) with significant unmet medical needs, including C3G, IgA nephropathy, atypical hemolytic uremic syndrome (aHUS), membranous nephropathy (MN) ), and the rare blood disease paroxysmal nocturnal hemoglobinuria (PNH)

The published Phase 2 data showed that: (1) treatment of IgAN with iptacopan reduced proteinuria and stabilized renal function; (2) treatment of C3G reduced the rate of decline of estimated glomerular filtration rate (eGFR) and stabilized renal function; (3) Treatment of PNH significantly reduces intravascular and extravascular hemolysis, enabling most patients to achieve rapid and long-lasting improvement without blood transfusion

Although Novartis has 35 years of history in the treatment of kidney transplantation, iptacopan is the first treatment for CDRD in the kidney disease treatment pipeline

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Original source: Novartis Pharmaceuticals UK awarded an Innovation Passport for investigational oral therapy iptacopan (LNP023)