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Mallinckrodt’s Terlipressin Narrowly Clears US FDA Panel As Need For Liver Treatment Outweighs Safety Worries

 
• By Brenda Sandburg

Advisory committee votes 8-7 to recommend approval for terlipressin to treat HRS-1 but is critical of Mallinckrodt’s plan to mitigate the risk of respiratory failure.

Liver
Mallinckrodt's terlipressin for hepatorenal syndrome gets nod from FDA panel • Source: Shutterstock

A US Food and Drug Administration panel was torn over whether Mallinckrodt plc's terlipressin for the rare life-threatening condition of hepatorenal syndrome provides clinical benefit that outweighs the risk of respiratory failure. But given the absence of any approved treatment and the chance it might give patients waiting a liver transplant more time, the panel voted 8-7 in favor of approval.

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