Novartis (NVS) said late Wednesday the US Food and Drug Administration granted accelerated approval for Vanrafia to reduce proteinuria in adults with primary immunoglobulin A nephropathy, or IgAN, at risk of rapid disease progression.
IgAN is a progressive, rare kidney disease.
Data from an ongoing phase III showed that Vanrafia achieved proteinuria reduction of about 36%, compared with placebo, with improvements seen at week six and sustained through week 36, as well as favorable safety, the company said.
It has not been established whether Vanrafia slows kidney function decline in patients with IgAN, the company said, adding that the continued approval could depend on longer term data from the ongoing phase III study, which will evaluate whether Vanrafia slows disease progression based on estimated glomerular filtration rate decline, with results expected in 2026.
Novartis shares were up 1.3% in recent premarket activity Thursday.
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.