Terlipressen Makes it Out of FDA Advisory Committee

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The drug Terlipressin (Mallinckrodt, Staines-upon-Thames, UK) made it out of an FDA advisory committee with an 8-7 vote for approval. At the recent Cardiovascular and Renal Drugs Advisory Committee meeting, participants pointed out benefits, but also some weaknesses of the drug, which was evaluated for its use in the treatment of hepatorenal syndrome type 1 (HRS-1). This kidney condition can develop in patients with acute or chronic liver disease with advanced liver failure and portal hypertension, and patients have poor survival rates.

Among other data, the FDA panel looked at data from a phase 3 trial of 300 patients, which