Fast Track designation for Terlipressin in type 1 hepatorenal syndrome

Protein Design Labs, Inc. and privately held Orphan Therapeutics, LLC today reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track status to the development of terlipressin for the treatment of patients with type 1 hepatorenal syndrome (HRS).

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. However, Fast Track designation does not mean that the FDA will expedite approval of the product nor does it increase the likelihood of approval of the product.

PDL's wholly-owned subsidiary, ESP Pharma, Inc., has acquired from Orphan Therapeutics exclusive marketing, sales and distribution rights for terlipressin in the United States and Canada. Orphan Therapeutics holds the U.S. investigational new drug application for terlipressin and is conducting a Phase III clinical trial in the United States and Europe.

Steven Benner, M.D., Chief Medical Officer, 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. We congratulate Orphan Therapeutics and look forward to their continued progress in developing this potentially life-saving therapeutic."

Peter Teuber, Ph.D., President of Orphan Therapeutics, said, "Working to address the significant unmet medical need in patients with type 1 HRS is the highest priority of our entire development team, and for all clinical experts involved in the Phase III trial around the country. The Fast Track status is a much welcomed recognition that a close and early interaction with the FDA on the development program, particularly for a small firm like ours, is critical to facilitate the development of terlipressin in patients with this life-threatening condition."