The Cardiovascular and Renal Drugs Advisory Committee of the U.S. Food and Drug Administration voted to recommend approval for Mallinckrodt’s investigational agent terlipressin to treat adults with hepatorenal syndrome type 1 (HRS-1).

Mallinckrodt plc announced positive top-line results from the company’s pivotal Phase 3 CONFIRM clinical study evaluating the efficacy and safety of terlipressin in 300 adults with hepatorenal syndrome type 1 (HRS-1).

Mallinckrodt plc announced that the company achieved target enrollment of 300 participants in the Phase 3 CONFIRM clinical study to evaluate the efficacy and safety of the investigational agent terlipressin in adult patients with Hepatorenal Syndrome Type 1 (HRS-1).