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Mallinckrodt Reports Positive Results of Terlipressin in P-III CONFIRM Study for Hepatorenal Syndrome Type 1

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Mallinckrodt Reports Positive Results of Terlipressin in P-III CONFIRM Study for Hepatorenal Syndrome Type 1

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  • The P-III CONFIRM study involves assessing of Terlipressin vs PBO in 300 adults with hepatorenal syndrome type 1 (HRS-1) in the US and Canada
  • The P-III CONFIRM study resulted in meting its 1EPs i.e- HRS-1 reversal as measured by improvement in renal function- avoidance of dialysis and short-term survival. In 2016- Mallinckrodt and the FDA signed an agreement on the CONFIRM study under the SPA process
  • Terlipressin is a vasopressin analogue selective for V1 receptors being investigated for the HRS-1 in the US and Canada with its expected NDA submission to the US FDA in H1’2020

Click here to­ read full press release/ article | Ref: PRNewswire | Image: Barrons


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