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

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

Mallinckrodt, Reports, Positive, Results, Terlipressin, P-III, CONFIRM, Study, Hepatorenal Syndrome Type 1

Shots:

  • 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

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

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