Mallinckrodt presents new TERLIVAZ for injection data on HRS reversal

Mallinckrodt announced the presentation of results from a retrospective analysis of three North American-centric, Phase III, randomized, placebo-controlled studies comparing the incidence of hepatorenal syndrome reversal with baseline acute-on-chronic liver failure grade in adults with rapid reduction in kidney function treated with TERLIVAZ plus albumin versus those treated with placebo plus albumin. TERLIVAZ is the first and only FDA-approved product indicated for the treatment of adults with HRS involving rapid reduction in kidney function, an acute and life-threatening condition requiring hospitalization. Terlipressin is recommended by the American Association for the Study of Liver Diseases guidance and the American College of Gastroenterology guidelines. The retrospective analysis used pooled data from the OT-0401, REVERSE, and CONFIRM Phase III studies to compare the incidence of HRS reversal by baseline ACLF grade in patients treated with terlipressin plus albumin versus placebo plus albumin for up to 14 days. Severity of ACLF was graded according to the number of organ failures. The incidence of HRS reversal was defined as at least one serum creatinine value of less than or equal to1.5 mg/dL while on treatment.