Terlipressin

BioVie Presents Positive Clinical Safety Data from Phase 2b Trial of BIV201 in Refractory Ascites at the American Association for the Study of Liver Disease (AASLD) - The Liver Meeting® 2023

Retrieved on: 
Monday, November 13, 2023
Hepatology, Cirrhosis, Safety, Randomness, Insulin resistance, Food, TIPS, Incidence, AASLD, Liver, Ascites, Abdomen, Hyponatremia, Patient, Confirmatory trial, Liver transplantation, Control, Survival rate, Inflammation, Liver support system, Terlipressin, Dementia, Standard of care, Acceleration, Orphan, SOC, Poster, Pharmaceutical industry, Medical imaging, Boston

CARSON CITY, Nev., Nov. 13, 2023 (GLOBE NEWSWIRE) -- BioVie Inc., (NASDAQ: BIVI) (“BioVie” or the “Company”) a clinical-stage company developing innovative drug therapies for the treatment of advanced liver disease and neurological and neurodegenerative disorders, today announced positive clinical safety data from the Company’s Phase 2b open-label study evaluating the efficacy and safety of BIV201, terlipressin administered as a continuous infusion, with standard of care (SOC) in patients with refractory ascites due to cirrhosis. The data will be highlighted today in a late-breaking poster presentation titled “Safety and Tolerability of Continuous Infusion Terlipressin (BIV201) In Patients with Decompensated Cirrhosis and Refractory Ascites: A Phase 2, Randomized, Controlled, Open-Label Study” at The American Association for the Study of Liver Diseases (AASLD) - The Liver Meeting® 2023 in Boston, MA.

Key Points: 
  • The incidence of treatment emergent adverse events (TEAEs), including serious TEAEs, was similar in both treatment groups.
  • Two patients who received BIV201 experienced hyponatremia that developed gradually, was asymptomatic, and was resolved upon discontinuation of the study drug.
  • Primary endpoints were safety and tolerability, and incidence of certain complications (Grade ≥2) during the 180 days following randomization.
  • BIV201, a continuous infusion of terlipressin, received Orphan Drug Designation for treatment of ascites from the U.S. Food and Drug Administration in 2017.

Mallinckrodt plc (in Examinership) Reports Third Quarter 2023 Financial Results

Retrieved on: 
Tuesday, November 7, 2023
Adjustment, Ratio, FDA, Risk, Security (finance), United States bankruptcy court, Result, Food, Bankruptcy, Conversation, Pressure, SG, EBITDA, GAAP, Nitric oxide, Research, R, Financial condition report, Ajman Specialty General Hospital, Growth, Attention deficit hyperactivity disorder predominantly inattentive, Shanda, Near-term digital radio, Analysis, The Company, Hospital, Public, Chapter 11, Title 11, United States Code, Food and Drug Administration, Patient, ADHD, Dietary supplement, Pharmaceutical industry, Video game, Fine chemical, Cryptocurrency, Medical device, Mallinckrodt, Terlipressin

DUBLIN, Nov. 7, 2023 /PRNewswire/ -- Mallinckrodt plc (in examinership) (OTCMKTS: MNKTQ) ("Mallinckrodt" or the "Company"), a global specialty pharmaceutical company, today reported its financial results for the third quarter ended September 29, 2023.

Key Points: 
  • Mallinckrodt's net sales in the third quarter of 2023 were $497.0 million, as compared to $465.4 million in the third quarter of 2022.
  • The Company recorded a net loss for the third quarter of $1,724.8 million, as compared to $284.9 million in the third quarter of 2022.
  • Adjusted gross profit as a percentage of sales was 66.3% for the third quarter of 2023, as compared to 66.2% for the third quarter of 2022.
  • Please see "Non-GAAP Financial Measures" included in this release for a discussion of non-GAAP measures and reconciliation of GAAP and non-GAAP financial measures for the third quarter.

BioVie Announces Late-Breaking Abstract Presenting Clinical Safety Data from the Company’s Ascites Phase 2 Trial Accepted for Presentation at AASLD – The Liver Meeting® 2023

Retrieved on: 
Thursday, October 26, 2023
Patient, Control, American Association for the Study of Liver Diseases, Hepatology, Cirrhosis, Liver, Terlipressin, Safety, AASLD, Pharmaceutical industry, Ascites

CARSON CITY, Nev., Oct. 26, 2023 (GLOBE NEWSWIRE) -- BioVie Inc., (NASDAQ: BIVI) (“BioVie” or the “Company”) a clinical-stage company developing innovative drug therapies for the treatment of advanced liver disease and neurological and neurodegenerative disorders, today announced that clinical safety data from the Company’s Phase 2 open-label study evaluating the efficacy and safety of BIV201, terlipressin administered as a continuous infusion, in patients with refractory ascites due to cirrhosis, will be highlighted in a late-breaking poster presentation at The American Association for the Study of Liver Diseases (AASLD) - The Liver Meeting® 2023 , taking place from November 10-14, 2023 in Boston, MA.

Key Points: 
  • CARSON CITY, Nev., Oct. 26, 2023 (GLOBE NEWSWIRE) -- BioVie Inc., (NASDAQ: BIVI) (“BioVie” or the “Company”) a clinical-stage company developing innovative drug therapies for the treatment of advanced liver disease and neurological and neurodegenerative disorders, today announced that clinical safety data from the Company’s Phase 2 open-label study evaluating the efficacy and safety of BIV201, terlipressin administered as a continuous infusion, in patients with refractory ascites due to cirrhosis, will be highlighted in a late-breaking poster presentation at The American Association for the Study of Liver Diseases (AASLD) - The Liver Meeting® 2023 , taking place from November 10-14, 2023 in Boston, MA.
  • The abstract titled “Safety and Tolerability of Continuous Infusion Terlipressin (Biv201) In Patients with Decompensated Cirrhosis and Refractory Ascites: A Phase 2, Randomized, Controlled, Open-Label Study” will be presented by Penelope Markham, Ph.D., BioVie’s Senior Vice President of Ascites and Strategic Initiatives on Monday November 13 from 1:00 PM – 2:00 PM.
  • Details of the presented data and conclusions will be announced once the presentations are made public at the conference.

Mallinckrodt to Present Data on TERLIVAZ® (terlipressin) for Injection in Adult Patients with Hepatorenal Syndrome (HRS) at the American College of Gastroenterology (ACG) Annual Scientific Meeting

Retrieved on: 
Sunday, October 22, 2023
Gastroenterology, FDA, Comorbidity, Hepatorenal syndrome, American College, Respiratory failure, PDT, EDT, Heart rate, Boxed warning, Oxygen saturation (medicine), Use, DBP, Physician, ACG, Cirrhosis, Mortality, Effect, Treatment, Post hoc analysis, MAP, SBP, Acute kidney injury, American College of Gastroenterology, Research, ACLF, Baylor University Medical Center, Phase, White, Chronic liver disease, Risk, Hospital, Maryland School, Volume overload, University, Stanford University School of Medicine, CLD, Blood pressure, HRS, Hypoxia, Pharmaceutical industry, Dietary supplement, Medical device, Nursing, Communications satellite, Mallinckrodt, Patient, MD, Terlipressin

DUBLIN, Oct. 22, 2023 /PRNewswire/ -- Mallinckrodt plc (OTCMKTS: MNKTQ), a global specialty pharmaceutical company, today announced that three posters detailing findings from Mallinckrodt's latest clinical and health economics outcomes research with TERLIVAZ® (terlipressin) for injection for adult patients with hepatorenal syndrome (HRS) with rapid reduction in kidney function1,2,3,4 will be presented at the American College of Gastroenterology (ACG) Annual Scientific Meeting in Vancouver, British Columbia, taking place October 20-25, 2023.

Key Points: 
  • Outcomes may be influenced by therapies not evaluated in the study and the clinical/health economic outcomes may not be solely attributable to TERLIVAZ.
  • TERLIVAZ® is indicated to improve kidney function in adults with hepatorenal syndrome with rapid reduction in kidney function.
  • For patients with high prioritization for liver transplantation (e.g., MELD ≥35), the benefits of TERLIVAZ may not outweigh its risks.
  • If TERLIVAZ is used during pregnancy, the patient should be informed of the potential risk to the fetus.

Mallinckrodt to Present Data on TERLIVAZ® (terlipressin) for Injection in Adult Patients with Hepatorenal Syndrome (HRS) at the European Association for the Study of the Liver (EASL) Congress 2023

Retrieved on: 
Thursday, June 15, 2023
University College London, PFS, EASL, ACLF, Use, Royal Free Hospital, HRS, SCR, International Club Crosby, Research, Transplant, MNK, Doctor of Philosophy, EDT, Bachelor of Science, Congress, California Pacific Medical Center, Volume overload, Hepatorenal syndrome, Oxygen saturation (medicine), MD, Patient, Risk, CEST, Boxed warning, Kidney, Diagnosis, Terlipressin, Hypoxia, European Association for the Study of the Liver, ICA, Digestate, UCL Institute of Ophthalmology, NYSE, Respiratory failure, Dietary supplement, Pharmaceutical industry, Nursing, Mallinckrodt, Liver

DUBLIN, June 15, 2023 /PRNewswire/ -- Mallinckrodt plc (NYSE American: MNK), a global specialty pharmaceutical company, today announced that two scientific posters detailing Mallinckrodt's latest research findings on the clinical outcomes of treatment with TERLIVAZ® (terlipressin) for injection and clinical management criteria for adult patients with hepatorenal syndrome (HRS) will be presented at the European Association for the Study of the Liver (EASL) Congress 2023 in Vienna, Austria, taking place June 21-24, 2023. Both posters will be presented on June 24, 2023, 9:00 a.m. – 5:00 p.m. CEST / 3:00 a.m. – 11:00 a.m. EDT.

Key Points: 
  • Both posters will be presented on June 24, 2023, 9:00 a.m. – 5:00 p.m. CEST / 3:00 a.m. – 11:00 a.m. EDT.
  • The CONFIRM trial is the largest-ever prospective, randomized clinical trial of terlipressin compared to placebo in patients with HRS type 1 (HRS-1).
  • Ineligibility for Liver Transplant: TERLIVAZ-related adverse reactions (respiratory failure, ischemia) may make a patient ineligible for liver transplantation, if listed.
  • For patients with high prioritization for liver transplantation (e.g., MELD ≥35), the benefits of TERLIVAZ may not outweigh its risks.

Mallinckrodt Presents Clinical Data for TERLIVAZ® (terlipressin) for Injection in Adults with Hepatorenal Syndrome (HRS) at Digestive Disease Week (DDW) 2023

Retrieved on: 
Monday, May 8, 2023
Gastrointestinal disease, Bradycardia, Use, HRS, Aes, Cardiovascular disease, MNK, Arrhythmia, DDW, Incidence, SS-N-22, Alcoholic hepatitis, Hepatorenal syndrome, Patient, Boxed warning, Virginia Commonwealth University, Internal medicine, School, Kidney, Terlipressin, NYSE, Pharmaceutical industry, Mallinckrodt

DUBLIN, May 8, 2023 /PRNewswire/ -- Mallinckrodt plc (NYSE American: MNK), a global specialty pharmaceutical company, today announced the presentation of results from two clinical studies for adults with hepatorenal syndrome (HRS) with rapid reduction in kidney function1 treated with TERLIVAZ® (terlipressin) for injection at Digestive Disease Week® (DDW) 2023, taking place in Chicago, Ill. from May 6-9. Mallinckrodt's pooled analysis of three North American Phase III studies on the incidence of adverse events (AEs) related to bradycardia and arrhythmias in adults with HRS treated with terlipressin was awarded Poster of Distinction status from DDW, and was presented on Sunday, May 7, 2023, 12:30 – 1:30 p.m. CDT.2 Additionally, Mallinckrodt's subgroup analysis of the CONFIRM Phase III study to assess terlipressin treatment outcomes in adults with HRS compounded by alcoholic hepatitis (AH) will be presented in an oral lecture session today, May 8, 2023, 10:30 – 10:45 a.m. CDT.3

Key Points: 
  • DUBLIN, May 8, 2023 /PRNewswire/ -- Mallinckrodt plc (NYSE American: MNK), a global specialty pharmaceutical company, today announced the presentation of results from two clinical studies for adults with hepatorenal syndrome (HRS) with rapid reduction in kidney function1 treated with TERLIVAZ® (terlipressin) for injection at Digestive Disease Week® (DDW) 2023, taking place in Chicago, Ill. from May 6-9.
  • The incidence of episodes of bradycardia was higher in terlipressin-treated patients (6.3%; n=22) compared with placebo-treated patients (0.8%; n=2; P
  • In CONFIRM (n=300), 41% (81/199) of patients in the terlipressin group and 39% (39/101) of the patients in the placebo group had AH at baseline.
  • In the subgroup of patients with AH (n=120), the median Maddrey discriminant function score was similar across treatment groups (terlipressin: 96.9 vs. placebo: 97.7; P=0.681).

BioVie Announces the Pausing of Patient Enrollment in Ascites Phase 2b Trial, Encouraging Efficacy Data is Announced, Initiating FDA Discussions to Conduct Pivotal Registrational Trial

Retrieved on: 
Monday, March 13, 2023
Paracentesis, Terlipressin, Liver, Publication, Nature Reviews Gastroenterology & Hepatology, Ascites, Cirrhosis, Abdomen, Temperature, Patient, Incidence, SOC, Standard of care, FDA, Grade 2, Cancer, Pharmaceutical industry, Hepatology, Medicine, Gastroenterology

This improvement was significantly different from those treated with SOC only who experienced a mean increase in ascites fluid of 3.1% (BIV201 vs. SOC p=0.05).

Key Points: 
  • This improvement was significantly different from those treated with SOC only who experienced a mean increase in ascites fluid of 3.1% (BIV201 vs. SOC p=0.05).
  • Patients who completed the treatment with BIV201 experienced a 53% reduction in ascites fluid (p=0.001), which was significantly different from those treated with SOC (p=0.007).
  • The current trial (NCT04112199) evaluates the efficacy of BIV201 combined with standard-of-care (SOC), compared to SOC alone, for the treatment of refractory ascites.
  • “Compelling data from the first 15 patients led us to pause enrollment,” commented Cuong Do, BioVie’s President and CEO.

Mallinckrodt to Present Data on TERLIVAZ® (terlipressin) for Injection in Adult Patients with Hepatorenal Syndrome (HRS) at the American Association for the Study of Liver Diseases (AASLD) 2022 Liver Meeting

Retrieved on: 
Thursday, November 3, 2022
Adult, Survival, Hepatorenal syndrome, ACLF, Division, Partial-response maximum-likelihood, University, MNK, University of Pennsylvania, Institute of Liver and Biliary Sciences, Acute kidney injury, Hypoxia, DC, AASLD, Kidney, American Association for the Study of Liver Diseases, Boxed warning, Safety, Volume overload, FDA, Association, Risk, Time, Oxygen saturation (medicine), HRS, Research, American Association, Efficacy, Terlipressin, NYSE, Mortality, Renal replacement therapy, 2021 Essex County Council election, Use, Health, Kidney failure, Completeness, ICA, Outcome, International Club Crosby, Pharmaceutical industry, Medical device, Poultry, Medicine, Gastroenterology, Patient, Mallinckrodt, Criterion, Hepatology

DUBLIN, Nov. 3, 2022 /PRNewswire/ -- Mallinckrodt plc (NYSE American: MNK), a global specialty pharmaceutical company, today announced that seven scientific abstracts on clinical and health economic outcomes research on treatment with TERLIVAZ® (terlipressin) for adult patients with hepatorenal syndrome (HRS) involving rapid reduction in kidney function,1 an acute and life-threatening condition requiring hospitalization2 will be presented at the American Association for the Study of Liver Diseases (AASLD) 2022 Liver Meeting in Washington, DC, from November 4-8. TERLIVAZ is the first and only FDA-approved product indicated to improve kidney function in adults with hepatorenal syndrome (HRS).1 

Key Points: 
  • Patients with volume overload or with acute-on-chronic liver failure (ACLF) Grade 3 are at increased risk.
  • Monitor patients for hypoxia using continuous pulse oximetry during treatment and discontinue TERLIVAZ if SpO2 decreases below 90%.
  • Serious or Fatal Respiratory Failure: Obtain baseline oxygen saturation and do not initiate TERLIVAZ in hypoxic patients.
  • For patients with high prioritization for liver transplantation (e.g., MELD 35), the benefits of TERLIVAZ may not outweigh its risks.

Mallinckrodt to Present Data on TERLIVAZ® (terlipressin) for Injection in Adult Patients with Hepatorenal Syndrome (HRS) at the American College of Gastroenterology (ACG) Annual Scientific Meeting

Retrieved on: 
Monday, October 24, 2022
CA, Terlipressin, Use, Risk, Oxygen saturation (medicine), Hepatorenal syndrome, American College of Gastroenterology, Patient, HRS, Mortality, Real, Kidney, Renal replacement therapy, ACG, Health, California Pacific Medical Center, Department, Disease, ACLF, Volume overload, Adult, Hypoxia, 2021 Essex County Council election, Survival, Boxed warning, American College, FDA, Kidney failure, Healthcare, Pharmaceutical industry, Transplant, Mallinckrodt

DUBLIN, Oct. 24, 2022 /PRNewswire/ -- Mallinckrodt plc (OTCMKTS: MNKPF), a global specialty pharmaceutical company, today announced that five scientific abstracts on the clinical and health economic outcomes of treatment with TERLIVAZ® (terlipressin) for adult patients with hepatorenal syndrome (HRS) involving rapid reduction in kidney function,1 will be presented at the American College of Gastroenterology (ACG) Annual Scientific Meeting in Charlotte, North Carolina from October 21-26. TERLIVAZ is the first and only FDA-approved product indicated to improve kidney function in adults with hepatorenal syndrome (HRS) with rapid reduction in kidney function,1 an acute and life-threatening condition requiring hospitalization.2

Key Points: 
  • "With the recent FDA approval of TERLIVAZ, we are hopeful that we are one step closer to improving outcomes for these critically ill patients."
  • Monitor patients for hypoxia using continuous pulse oximetry during treatment and discontinue TERLIVAZ if SpO2 decreases below 90%.
  • Serious or Fatal Respiratory Failure: Obtain baseline oxygen saturation and do not initiate TERLIVAZ in hypoxic patients.
  • For patients with high prioritization for liver transplantation (e.g., MELD 35), the benefits of TERLIVAZ may not outweigh its risks.

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

Retrieved on: 
Thursday, September 15, 2022
Hospital, Terlipressin, Dialysis, Therapy, Safety, Trial of the century, Liver support system, Hypoxia, Hepatorenal syndrome, American College, AASLD, Risk, FDA, Food, Breathe Me, Diarrhea, American Association for the Study of Liver Diseases, American Association, ACG, Verified, Renal replacement therapy, Survival, Oxygen saturation (medicine), Patient, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Severe cutaneous adverse reactions, The New England Journal of Medicine, Physician, 2021 Essex County Council election, Terminology, Use, American College of Gastroenterology, Volume overload, Caregiver, Boxed warning, Kidney failure, SCR, Abdominal pain, Association, Nausea, Mortality, Kidney, ACLF, HRS, Institute of Liver and Biliary Sciences, Pharmaceutical industry, Mallinckrodt

DUBLIN, Sept. 14, 2022 /PRNewswire/ -- Mallinckrodt plc (OTCMKTS: MNKPF), a global specialty pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) approved Terlivaz® (terlipressin) for injection. Terlivaz is the first and only FDA-approved product indicated to improve kidney function in adults with hepatorenal syndrome (HRS) with rapid reduction in kidney function,1 an acute and life-threatening condition requiring hospitalization.2 

Key Points: 
  • DUBLIN, Sept. 14, 2022 /PRNewswire/ -- Mallinckrodt plc (OTCMKTS: MNKPF), a global specialty pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) approved Terlivaz (terlipressin) for injection.
  • The CONFIRM trial was completed prior to the updated diagnostic criteria and terminology published in the 2021 AASLD guidance on hepatorenal syndrome.
  • * Note, Terlivaz was not evaluated in comparison to other treatment options in a head-to-head clinical study.
  • Monitor patients for hypoxia using continuous pulse oximetry during treatment and discontinue TERLIVAZ if SpO2 decreases below 90%.