07:55 AM EDT, 09/06/2024 (MT Newswires) -- Travere Therapeutics ( TVTX ) said late Thursday the US Food and Drug Administration has granted full approval to Filspari, which is intended to slow kidney function decline in adults with primary IgA nephropathy who are at risk of disease progression.
Shares of the company rose more than 7% in recent premarket activity.
Filspari was granted accelerated approval in February 2023 and the full approval is now based on positive results from the PROTECT study.
The final analysis of 404 randomized patients in the study showed that Filspari "significantly" reduced the rate of decline in kidney function over two years compared with irbesartan, the company said.
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