Clinical Trial Research
Orphan Therapeutics Announces Initiation of Rolling NDA Submission for LUCASSIN(R) (terlipressin) for the Treatment of Hepatorenal Syndrome Type 1
Published in Medical Letter on the CDC and FDA, June 15th, 2008
Orphan Therapeutics announced that it has begun submission of the rolling LUCASSIN(R) (terlipressin) New Drug Application (NDA) for the treatment of hepatorenal syndrome (HRS) type 1 in patients with late-stage liver cirrhosis. LUCASSIN(R) had previously been granted orphan status and fast track designation for this indication by the U.S. Food and Drug Administration (FDA). Currently no drug is approved in the U.S. to treat HRS type 1, a rare and life-threatening condition in late-stage liver disease.
The LUCASSIN(R) rolling NDA submission is based on the results from OT-0401,(1) a randomized, double-blind, multi-center, placebo-controlled Phase III study in 112...
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