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US FDA Advisory Cmte. To Evaluate Terlipressin's Clinical Outcomes, Risk Of Respiratory Failure

 
• By Brenda Sandburg

Mallinckrodt's drug to treat hepatorenal syndrome met its primary endpoint of HRS reversal but FDA wants reassurance that this surrogate endpoint translates into a treatment effect on clinical outcomes. A greater incidence of respiratory failure in those receiving terlipressin "remains a significant safety concern," the agency says.

Human Body Organs Anatomy (Liver)
Mallinckrodt drug to treat life-threatening hepatorenal syndrome gets advisory committee review • Source: Shutterstock

Mallinckrodt plc's terlipressin for hepatorenal syndrome, a life-threatening condition involving acute kidney failure in people with cirrhosis, has had a difficult path at the US Food And Drug Administration and may face more hurdles as it goes before an advisory committee.

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‘Pipeline In A Pill’ Or Pipe Dream? US FDA’s April Goal Dates Test Expansion Strategies

 
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Global Pharma Guidance Tracker – February 2025

 
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Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.

EU CHMP Opinions And MAA Updates

 
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