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Mallinckrodt’s Terlivaz (terlipressin) Receives the US FDA’s Approval for the Treatment of Hepatorenal Syndrome

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Mallinckrodt’s Terlivaz (terlipressin) Receives the US FDA’s Approval for the Treatment of Hepatorenal Syndrome

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  • The US FDA has approved Terlivaz (terlipressin) in adults with hepatorenal syndrome (HRS) involving a rapid reduction in kidney function. The therapy is expected to be available in the US in the coming weeks
  • The approval was based on the P-III (CONFIRM) trial to evaluate the safety and efficacy of terlipressin in patients with HRS-1 across the US and Canada
  • The trial met its 1EPs of verified HRS reversal which was defined as renal function improvement, avoidance of dialysis, and short-term survival, patients had to be alive at least 10 days after attaining verified HRS reversal and not be receiving any renal replacement therapy during that time

Ref: PRNewswire | Image: Mallinckrodt

Click here to­ read the full press release 

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Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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