04:35 AM EDT, 08/08/2024 (MT Newswires) -- Novartis ( NVS ) said late Wednesday the US Food and Drug Administration granted accelerated approval for its Fabhalta therapy to reduce proteinuria in certain adults with primary immunoglobulin A nephropathy, a chronic kidney disease.

The accelerated approval was based on the pre-specified interim analysis of a phase 3 study.

"It has not been established whether Fabhalta slows kidney function decline in patients with IgAN," the company said. "The continued approval of Fabhalta may be contingent upon verification and description of clinical benefit" from the ongoing phase 3 trial.

That data is expected in 2025 and is planned to support traditional FDA approval, Novartis ( NVS ) said.

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