FDA Cardiovascular and Renal Drugs Advisory Committee voted 8-7 to recommend approval of terlipressin for the treatment of hepatorenal syndrome type 1 in patients with cirrhosis.
Terlipressin, developed by Mallinckrodt plc, is an investigational agent that consists of a synthetic, 12-amino-acid peptide analog of vasopressin.
“I voted ‘yes’ albeit with some reservation,” David N. Assis, MD, said during his final remarks. “Currently there is nothing else available or close to effective to give these patients. The benefit vs. risk is a critical issue today and a