FDA approves Mallinckrodt kidney drug

Sept. 15, 2022

Irish-American drugmaker Mallinckrodt announced yesterday that the FDA has approved Terlivaz (terlipressin), for use in hospitalized adults with hepatorenal syndrome (HRS) who are presenting a rapid reduction in kidney function. 

Hepatorenal syndrome can be diagnosed as either rapidly progressing/acute, or chronic. The disorder affects up to 1 in 10 people who are in the hospital with liver failure, and if left untreated, has median survival time of two weeks.

The recent approval hinged on results from the phase 3 CONFIRM trial, which assessed the safety of Terlivaz in 300 participants. Mallinckrodt reported that the trial met its primary endpoint of reversing HRS as defined by renal function improvements, avoidance of dialysis and short-term survival. 

Terlivaz is given as an injection and is thought to work by reducing portal hypertension and blood circulation in portal vessels, helping to increase effective arterial volume and pressure.