Advisory Committee to meet to review data for terlipressin to treat hepatorenal syndrome.- Mallinckrodt

Mallinckrodt Plc ,announced that the Cardiovascular And Renal Drugs Advisory Committee of the FDA will, as expected, hold a virtual meeting to review data on terlipressin, an investigational agent being evaluated for the treatment of hepatorenal syndrome type 1 (HRS-1). The company announced the FDA accepted for review its New Drug Application (NDA) for terlipressin in April.

HRS-1 is an acute and life-threatening syndrome involving acute kidney failure in people with cirrhosis. The condition has a median survival time of approximately two weeks and greater than 80 percent mortality within three months if left untreated. At present, there are no approved drug therapies for HRS-1 in the U.S., and it is estimated to affect between 30,000 and 40,000 patients in the U.S. annually.