Novartis' Fabhalta Receives FDA Traditional Approval for Primary IgA Nephropathy
MT Newswires Live
Jul 17
Novartis (NVS) said Friday that the US Food and Drug Administration approved Fabhalta under the traditional approval pathway to slow kidney function decline in adults with primary immunoglobulin A nephropathy at risk of disease progression.
The approval was based on the phase 3 APPLAUSE-IgAN trial, in which Fabhalta slowed estimated glomerular filtration rate decline by 48% versus placebo over two years and demonstrated clinically meaningful reductions in proteinuria as early as two weeks, Novartis said.
Fabhalta previously received accelerated FDA approval in August 2024 to reduce proteinuria in patients with primary IgA nephropathy, it added.
Disclaimer: Investing carries risk. This is not financial advice. The above content should not be regarded as an offer, recommendation, or solicitation on acquiring or disposing of any financial products, any associated discussions, comments, or posts by author or other users should not be considered as such either. It is solely for general information purpose only, which does not consider your own investment objectives, financial situations or needs. TTM assumes no responsibility or warranty for the accuracy and completeness of the information, investors should do their own research and may seek professional advice before investing.