FDA accepts filing of new drug application (NDA) for terlipressin for treatment of hepatorenal syndrome type 1 (HRS-1)

NDA is based, in part, on CONFIRM trial, the largest-ever prospective study (n=300) in HRS-1, an acute and life-threatening syndrome involving acute kidney failure in people with cirrhosis.1, with median survival time of ~ 2 weeks and > 80% mortality within 3-months if untreated.


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