Novartis announces that it has received accelerated approval from the US FDA for its Fabhalta (iptacopan), as the first and only complement inhibitor for the reduction of proteinuria in primary IgA nephropathy (IgAN).

This indication is based on the pre-specified interim analysis of the Phase III APPLAUSE-IgAN study measuring the reduction in proteinuria at nine months versus placebo, which has not yet established whether Fabhalta slows the decline in renal function.

Continued approval of Fabhalta may depend on verification and description of the clinical benefits of the ongoing APPLAUSE-IgAN phase III study, assessing whether Fabhalta slows disease progression.

The latter will be measured by estimated glomerular filtration rate (eGFR) over 24 months, data expected at study completion in 2025 and which are intended to support traditional FDA approval.

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