Pharmacy Times August 8, 2024
The indication is for the reduction of proteinuria in adult patients who have primary immunoglobulin A nephropathy and are at risk of disease progression.
The FDA has granted an accelerated approval to iptacopan (Fabhalta; Novartis) for the reduction of proteinuria in adult patients with primary immunoglobulin A nephropathy (IgAN) who are at risk of disease progression. Proteinuria is defined as a urine protein-to-creatine ratio (UPCR) of 1.5 g/g or more. The accelerated approval is based on the pre-specified interim analysis of the phase 3 APPLAUSE-IgAN trial (NCT04578834), and the continued approval of iptacopan may be dependent upon the verification and description of clinical benefit in this study.1
IgAN is a progressive and rare disease in which the immune system attacks...
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