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news.Orphan Therapeutics has initiated submission of the rolling Lucassin new drug application for the treatment of hepatorenal syndrome type 1 in patients with late-stage liver cirrhosis.
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The Lucassin rolling new drug application (NDA) submission is based on the results from OT-0401, a randomized, double-blind, multi-center, placebo-controlled Phase III study in 112 patients with hepatorenal syndrome (HRS) type 1 conducted by Orphan Therapeutics. It is also independently supported by TAHRS, a second randomized, multi-center, controlled study in 46 patients coordinated by the University of Barcelona.
Orphan Therapeutics holds exclusive rights to the TAHRS data for the NDA submission. The rolling submission process enables companies that have been granted fast track designation to submit sections of the NDA to the FDA as they become available.