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news.Protein Design Labs and Orphan Therapeutics have revealed that the FDA has granted fast track status to the development of terlipressin for the treatment of patients with type 1 hepatorenal syndrome.
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Protein Design Labs (PDL)’s wholly-owned subsidiary, ESP Pharma, has acquired from Orphan Therapeutics exclusive marketing, sales and distribution rights for terlipressin in the US and Canada. Orphan Therapeutics holds the US investigational new drug application for terlipressin and is conducting a phase III clinical trial in the US and Europe.
Designation as a fast track product indicates that the FDA will facilitate the development and expedite the review of a new drug that is intended to treat a serious or life-threatening condition, and that demonstrates the potential to address an unmet medical need.
Dr Steven Benner, chief medical officer of PDL, said, “Fast track status is a significant step in Orphan Therapeutics’ efforts to develop and ultimately gain approval for terlipressin in an indication for which there is no approved therapy.”
Hepatorenal syndrome (HRS) is the development of a functional renal failure in patients with end-stage liver disease in the absence of any other cause of renal pathology. Type 1 HRS is characterized by rapid deterioration of renal function, with a median survival time of less than two weeks, unless liver transplantation is performed.