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SEPTEMBER 15, 2022

FDA Approves Terlivaz for Hepatorenal Syndrome in Adults

By PPN News Staff

The FDA approved terlipressin (Terlivaz, Mallinckrodt) for adults with hepatorenal syndrome (HRS) involving rapid reduction in kidney function. The vasopressin receptor agonist is the first medication to receive approval for this condition.


The approval was based on results from a multicenter, placebo-controlled, phase 3 clinical trial, which were published in The New England Journal of Medicine last year (2021;384[9]:818-828). Participants were randomly assigned to receive an