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