In the News

Mallinckrodt plc, a global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding the Company's New Drug Application (NDA) seeking approval for the investigational agent terlipressin to treat adults with hepatorenal syndrome (HRS), an acute and life-threatening syndrome involving rapid reduction in kidney function for which there is currently no FDA-approved treatment. ...click title to read full article

Mallinckrodt plc (NYSE: MNK), a global biopharmaceutical company, today announced positive top-line results from its pivotal Phase 3 CONFIRM clinical study evaluating the efficacy and safety of terlipressin in 300adults with hepatorenal syndrome type 1 (HRS-1). The study met its primary endpoint of verified HRS-1 reversal (p=0.012). Verified HRS-1 reversal includes three components: renal function improvement, avoidance of dialysis and short-term survival. The company plans to present the data at anupcoming medical meeting. ...click title to read full article

Mallinckrodt plc (NYSE: MNK), a leading global specialty biopharmaceutical company, is holding its investor briefing today in New York City with presentations by Mark Trudeau, President and Chief Executive Officer of Mallinckrodt and Steve Romano, M.D., Chief Scientific Officer. Mallinckrodt's "acquire to invest" operating model is driving the ongoing transformation of the company's business, providing long-term value for patients and shareholders. Appropriate patients benefit from broadened access to critical medications, bolstered long-term by the company's ongoing and significant investment in achieving the products' full potential through developing compelling clinical and health economic data, engaging with payers and expanding product availability through additional indications, enabling volume growth. ...click title to read full article

Mallinckrodt plc (NYSE: MNK), a leading specialty biopharmaceutical company, today announced that it has completed its acquisition of Ikaria, Inc. at a purchase price of approximately$2.3 billion. The Ikaria acquisition extends Mallinckrodt's footprint in the hospital market and expands its reach into neonatal critical care with INOMAX® (inhaled nitric oxide), a vital treatment option for a highly vulnerable patient population. It also accelerates Mallinckrodt's rapid growth in specialty brands -- adding significant portfolio diversity with a high-value, high-margin integrated drug-device-service product offering. ...click title to read full article

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. ...click title to read full article

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. ...click title to read full article

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....click title to read full article

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. ...click title to read full article

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.

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. ...click title to read full article

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. ...click title to read full article

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Mallinckrodt Receives U.S. FDA Approval for Terlivaz® (terlipressin) for injection for the Treatment of Hepatorenal Syndrome (HRS)

Terlivaz is the first and only FDA-approved treatment for adults with HRS involving rapid reduction in kidney function.

September 14, 2022

Mallinckrodt Announces Resubmission of Terlipressin to the FDA for the Treatment of Hepatorenal Syndrome

June 13, 2022

Mallinckrodt Provides a Regulatory Update on Terlipressin

February 22, 2022

Mallinckrodt Announces New England Journal of Medicine Publication of Results from its Phase 3 CONFIRM Study of Terlipressin in Patients with Hepatorenal Syndrome Type 1 (HRS-1)

March 4, 2021

Mallinckrodt Announces﻿ FDA Advisory Committee Voted to Recommend Terlipressin for Approval to Treat Patients with Hepatorenal Syndrome Type 1 (HRS-1)

July 15, 2020

Mallinckrodt Presents Positive Phase 3 Results from its CONFIRM Study of Terlipressin in Patients with Hepatorenal Syndrome Type1 (HRS-1) at The Liver Meeting 2019

November 11, 2019

Mallinckrodt to Present Results from its Pivotal Phase 3 CONFIRM Study of Terlipressin in Patients with Hepatorenal Syndrome Type 1 (HRS-1) at The Liver Meeting 2019

October 21, 2019

Mallinckrodt Announces Positive Top-Line Results from its Pivotal Phase 3 CONFIRM Trial of Terlipressin in Patients with Hepatorenal Syndrome Type 1 (HRS-1)

August 15, 2019

Mallinckrodt plc Discusses R&D Initiatives, Company Outlook at Investor Briefing

December 7, 2015

Mallinckrodt Completes Acquisition of Ikaria

April 16, 2015

Lucassin® Approved in Australia

April 23, 2012

IKARIA Begins Enrollment of Pivotal Trial for Lucassin®

November 30, 2010

IKARIA Acquires New Drug Application for Lucassin®

March 30, 2010

FDA Accepts Final Section of NDA Filing for Lucassin®

June 12, 2009

Ikaria Acquires North American Rights to Lucassin® from Orphan Therapeutics

September 2, 2008

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

May 28, 2008

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

November 4, 2007

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

December 18, 2006

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

October 30, 2006

Orphan Therapeutics, LLC

Sarasota, FLorida, usa

Mallinckrodt Announces FDA Advisory Committee Voted to Recommend Terlipressin for Approval to Treat Patients with Hepatorenal Syndrome Type 1 (HRS-1)