Therapy Areas: Cardiovascular
US FDA committee votes to recommend approval of Mallinckrodt's Terlipressin
16 July 2020 -

The United States Food and Drug Administration's (FDA) Cardiovascular and Renal Drugs Advisory Committee has voted to recommend the approval of United Kingdom-based Mallinckrodt plc's (NYSE: MNK) investigational agent Terlipressin, intended to treat adults with hepatorenal syndrome type 1 (HRS-1), an acute and life-threatening syndrome involving acute kidney failure in people with cirrhosis, it was reported on Wednesday.

The product is an investigational agent that is being assessed for the treatment of HRS-1 in the US, and its safety and effectiveness have not yet been revealed by the US FDA. It is a potent vasopressin analogue selective for V1 receptors. If approved, terlipressin would be the first FDA-approved treatment in the US for adult patients with HRS-1, a life-threatening condition

The US FDA accepted for review the company's New Drug Application (NDA) for the product in April 2020 based on results from the phase three CONFIRM trial. It has assigned the product a Prescription Drug User Fee Act (PDUFA) target date of 12 September 2020.

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