April 23, 2012

Lucassin^® Approved in Australia

Ikaria, Inc., a critical care company focused on developing and commercializing innovative therapies for critically ill patients, announced today the approval of LUCASSIN® (terlipressin) by the Therapeutic Goods Administration (TGA) of Australia. LUCASSIN is approved for the treatment of Hepatorenal Syndrome Type 1 (HRS 1) in patients who are actively being considered for a liver transplant. HRS Type 1 is the development of kidney failure in patients with advanced liver cirrhosis in the absence of any other cause. It is characterized by rapid onset of renal failure with a high mortality rate that exceeds 80% within three months. The only cure is a liver transplant.

LUCASSIN is a synthetic vasopressin analogue that acts via the vasopressin V1 receptor as a systemic vasoconstrictor, mainly in the splanchnic (abdominal) circulation, which appears to increase effective arterial volume and improves renal blood flow, thereby improving renal function in patients with HRS.  Read more...

March 30, 2010

IKARIA^® Acquires New Drug Application for Lucassin^®
Investigational New Drug Application Also Acquired

Ikaria Holdings, Inc. announced today that it has acquired the New Drug Application (NDA) and the Investigational New Drug (IND) application, to LUCASSIN® (terlipressin for injection) from Orphan Therapeutics, assuming all future development and ownership of the drug in North America and Australia. LUCASSIN is being developed for the treatment of hepatorenal syndrome (HRS) Type 1, an orphan-designated condition for which there currently are no approved drugs in the U.S   Read more...

June 12, 2009

FDA Accepts Final Section of NDA Filing for Lucassin^®
Priority Review Granted

Orphan Therapeutics, LLC and Ikaria Holdings, Inc. announced today that the U.S. Food and Drug Administration (FDA) has accepted the final section of the New Drug Application (NDA) filing seeking marketing approval for LUCASSIN® (terlipressin for injection) for the treatment of hepatorenal syndrome (HRS) Type 1. The filing was completed on May 4, 2009, and LUCASSIN has been granted Priority Review, as well as Orphan Drug status and Fast Track designation.   Read more...

September 2, 2008

Ikaria^® Acquires North American Rights to Lucassin^® from Orphan Therapeutics
No Currently Approved Drugs to Treat Hepatorenal Syndrome Type 1 in U.S.

Ikaria Holdings, Inc. and Orphan Therapeutics, LLC announced today that they have entered into an agreement under which Ikaria has acquired rights to LUCASSIN® (terlipressin) in North America from Orphan Therapeutics.

Orphan Therapeutics has initiated a rolling NDA with the U.S. Food and Drug Administration (FDA) seeking marketing approval for LUCASSIN® for the treatment of hepatorenal syndrome (HRS) Type 1. LUCASSIN® has been granted orphan drug status and fast-track designation.  Following marketing approval of LUCASSIN®, Orphan Therapeutics will transfer North American rights to Ikaria, which will then be responsible for its post-market development and commercialization.   Read more...

May 28, 2008

Orphan Therapeutics Announces Initiation of Rolling NDA Submission for LUCASSIN^® (terlipressin) for the Treatment of Hepatorenal Syndrome Type 1

Orphan Therapeutics today announced that it has begun submission of the rolling LUCASSIN® (terlipressin) New Drug Application (NDA) for the treatment of Hepatorenal Syndrome (HRS) type 1 in patients with late-stage liver cirrhosis. LUCASSIN® 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. Read more...

November 4, 2007

Five (5) Terlipressin Abstracts Presented at AASLD 2007 and ASN 2007

Four terlipressin abstracts were presented at AASLD.  Abstract #737 presented prognostic factors for HRS reversal based on results from the clinical trial OT-0401.  This poster was selected as a Presidential Poster of Distinction representing the top 10% of all abstracts at AASLD.  The other 3 abstracts (#742, #815 and LB13) were from independent authors, investigating terlipressin. 

Another terlipressin abstract and poster was presented at the American Society of Nephrology 2007 meeting examining terlipressin effect on creatinine clearance as calculated from OT-0401 data.

December 18, 2006

Orphan Therapeutics Announces Rolling NDA Submission for LUCASSIN™ (terlipressin) to Treat Type 1 Hepatorenal Syndome

Orphan Therapeutics announced today plans to initiate a rolling submission in the second quarter of 2007 for a New Drug Application (NDA) with the FDA to commercialize LUCASSIN™ (terlipressin), its drug candidate for treating type 1 hepatorenal syndrome (HRS)....The rolling submission process enables companies that have been granted fast track designation by the FDA to submit sections of the NDA to the agency as they become available. The FDA grants fast track status to drug candidates that treat serious or life-threatening conditions, and that demonstrate the potential to address unmet medical needs. Terlipressin received fast track status in April 2005 for type 1 HRS, and orphan drug designation in October 2004. Read more...

October 30, 2006

Late-Breaking Presentation at Liver Meeting Details Results of Phase 3 Study of terlipressin for Type 1 Hepatorenal Syndrome

At a late-breaking oral presentation today at the 57th Annual Meeting of the American Association for the Study of Liver Diseases, topline results of a Phase 3 clinical trial for terlipressin indicated positive trends in treatment for type 1 Hepatorenal Syndrome (HRS). The study, conducted by Orphan Therapeutics, was the first randomized, double-blind, placebo-controlled clinical trial of terlipressin in type 1 HRS in the United States. HRS is a life-threatening condition characterized by rapid kidney failure in patients with end-stage liver cirrhosis. Continue reading this press release, including the abstract article from AASLD, by clicking here.