Advisory Committee Meeting recommends terlipressin to treat adults with hepatorenal syndrome type 1.- Mallinckrodt

Mallinckrodt Plc announced that the Cardiovascular And Renal Drugs Advisory Committee of the U.S. FDA voted to recommend approval for its investigational agent terlipressin to treat adults with hepatorenal syndrome type 1 (HRS-1) (8 yes; 7 no). HRS-1 is an acute and life-threatening syndrome involving acute kidney failure in people with cirrhosis. Terlipressin is an investigational agent being evaluated for the treatment of HRS-1 in the U.S., and its safety and effectiveness have not yet been established by the FDA.

HRS-1 requires a diagnosis of exclusion, and is often a challenge to diagnose in a timely manner. If left untreated, HRS-1 has a median survival time of approximately two weeks and greater than 80 percent mortality within three months. 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 Americans annually.