Mallinckrodt to Present Data on TERLIVAZ® (terlipressin) for Injection at the 2024 American Association for the Study of Liver Diseases (AASLD) Annual Meeting
Mallinckrodt announced the presentation of four posters on TERLIVAZ® (terlipressin) at The Liver Meeting 2024. The research focuses on patients with hepatorenal syndrome (HRS) with rapid kidney function reduction, affecting approximately 42,000 Americans annually.
The presentations include pooled data from Phase 3 studies examining: the impact of waiting until Day 4 for assessing HRS reversal, the effect of obesity on HRS reversal, and outcomes in patients treated with standard versus high doses. An additional analysis from the CONFIRM study explores TERLIVAZ's impact on HRS reversal, liver transplant rates, and MELD scores.
TERLIVAZ is the first FDA-approved treatment to improve kidney function in adults with HRS with rapid reduction in kidney function, a rare and life-threatening condition requiring hospitalization.
Mallinckrodt ha annunciato la presentazione di quattro poster su TERLIVAZ® (terlipressina) in occasione del The Liver Meeting 2024. La ricerca si concentra su pazienti con sindrome epatorenale (HRS) con rapida riduzione della funzione renale, che colpisce circa 42.000 americani all'anno.
Le presentazioni includono dati aggregati da studi di Fase 3 che esaminano: l'impatto dell'attesa fino al Giorno 4 per valutare la reversibilità dell'HRS, l'effetto dell'obesità sulla reversibilità dell'HRS e i risultati in pazienti trattati con dosi standard rispetto a dosi elevate. Un'ulteriore analisi dello studio CONFIRM esplora l'impatto di TERLIVAZ sulla reversibilità dell'HRS, sui tassi di trapianto di fegato e sui punteggi MELD.
TERLIVAZ è il primo trattamento approvato dalla FDA per migliorare la funzione renale negli adulti con HRS con rapida riduzione della funzione renale, una condizione rara e minacciosa per la vita che richiede ospedalizzazione.
Mallinckrodt anunció la presentación de cuatro carteles sobre TERLIVAZ® (terlipresina) en The Liver Meeting 2024. La investigación se centra en pacientes con síndrome hepatorrenal (HRS) con una reducción rápida de la función renal, que afecta a aproximadamente 42,000 estadounidenses anualmente.
Las presentaciones incluyen datos agrupados de estudios de Fase 3 que examinan: el impacto de esperar hasta el Día 4 para evaluar la reversibilidad del HRS, el efecto de la obesidad en la reversibilidad del HRS, y los resultados en pacientes tratados con dosis estándar frente a dosis altas. Un análisis adicional del estudio CONFIRM explora el impacto de TERLIVAZ en la reversibilidad del HRS, las tasas de trasplante de hígado y las puntuaciones MELD.
TERLIVAZ es el primer tratamiento aprobado por la FDA para mejorar la función renal en adultos con HRS con reducción rápida de la función renal, una condición rara y potencialmente mortal que requiere hospitalización.
몰린크로트는 The Liver Meeting 2024에서 TERLIVAZ® (테르리프레신)에 대해 네 개의 포스터 발표를 하였다고 발표했습니다. 이 연구는 급격히 신장 기능이 감소하는 간신 증후군(HRS) 환자에 초점을 맞추고 있으며, 매년 약 42,000명의 미국인이 영향을 받고 있습니다.
발표 내용에는 HRS 환자의 역전 평가를 위해 4일까지 기다리는 것의 영향, HRS 역전에서 비만의 효과, 표준 용량과 고용량으로 치료받은 환자들의 결과를 살펴보는 3상 연구의 데이터가 포함되어 있습니다. 추가적으로 CONFIRM 연구의 분석은 HRS 역전, 간 이식률 및 MELD 점수에 대한 TERLIVAZ의 영향을 조사합니다.
TERLIVAZ는 신장 기능이 급격히 감소한 HRS를 가진 성인을 위한 첫 번째 FDA 승인 치료제로, 이는 입원이 필요한 드문 생명 위협적 상태입니다.
Mallinckrodt a annoncé la présentation de quatre affiches sur TERLIVAZ® (térelipressine) lors de The Liver Meeting 2024. La recherche se concentre sur les patients atteints du syndrome hépatonéphrique (HRS) avec une réduction rapide de la fonction rénale, affectant environ 42 000 Américains chaque année.
Les présentations incluent des données agrégées d'études de Phase 3 examinant : l'impact d'attendre jusqu'au Jour 4 pour évaluer la réversibilité de l'HRS, l'effet de l'obésité sur la réversibilité de l'HRS, et les résultats chez les patients traités avec des doses standard par rapport à des doses élevées. Une analyse supplémentaire de l'étude CONFIRM explore l'impact de TERLIVAZ sur la réversibilité de l'HRS, les taux de transplantation hépatique et les scores MELD.
TERLIVAZ est le premier traitement approuvé par la FDA pour améliorer la fonction rénale chez les adultes atteints de HRS avec une réduction rapide de la fonction rénale, une condition rare et menaçante pour la vie nécessitant une hospitalisation.
Mallinckrodt gab die Präsentation von vier Postern zu TERLIVAZ® (Terlipressin) auf dem The Liver Meeting 2024 bekannt. Die Forschung konzentriert sich auf Patienten mit hepatorenalem Syndrom (HRS), die eine schnelle Verschlechterung der Nierenfunktion erfahren, was jährlich etwa 42.000 Amerikaner betrifft.
Die Präsentationen enthalten aggregierte Daten aus Phase-3-Studien, die den Einfluss des Wartens bis zum Tag 4 zur Beurteilung der HRS-Reversion, die Auswirkungen von Fettleibigkeit auf die HRS-Reversion und Ergebnisse bei Patienten, die mit Standard- gegenüber Hochdosen behandelt wurden, untersuchen. Eine zusätzliche Analyse aus der CONFIRM-Studie untersucht den Einfluss von TERLIVAZ auf die HRS-Reversion, die Lebertransplantationsraten und die MELD-Werte.
TERLIVAZ ist die erste von der FDA zugelassene Behandlung zur Verbesserung der Nierenfunktion bei Erwachsenen mit HRS und schneller Verschlechterung der Nierenfunktion, einer seltenen und lebensbedrohlichen Erkrankung, die eine Hospitalisierung erfordert.
- None.
- None.
– Four posters highlight TERLIVAZ research on the potential impact of dosing and outcomes in key subpopulations of adults with HRS with rapid reduction in kidney function1 –
TERLIVAZ is the first and only FDA-approved product indicated to improve kidney function in adults with HRS with rapid reduction in kidney function,1 an acute and life-threatening condition requiring hospitalization.2 HRS involving rapid reduction in kidney function1 is estimated to affect more than 42,000 Americans annually, approximately
Please see Limitation of Use and Important Safety Information, including Boxed Warning, below.
Three posters include pooled data from Phase 3 placebo-controlled studies with TERLIVAZ, examining the potential impact of waiting until Day 4 and after 12 doses before assessing HRS reversal; the effect of obesity, as measured by body mass index (BMI), on HRS reversal; and HRS reversal in patients treated with the standard dose and high dose. The fourth poster is an analysis of the Phase 3 CONFIRM study, examining the potential impact of TERLIVAZ treatment on HRS reversal, liver transplant rates, and Model for End-Stage Liver Disease (MELD) scores.
"The data being presented at AASLD expand our knowledge for several subpopulations of HRS patients where there is a critical need and broaden our understanding of potential HRS reversal," said Peter Richardson, MRCP (
Poster #4094: Patience is a Virtue: Evidence for Waiting Until Day 4 and After 12 Doses of Terlipressin Before Evaluating Treatment Response in Patients with HRS-AKI5
- Presenter: Manhal J. Izzy
- Session Type: Poster Presentation
- Session Title: Portal Hypertension and Other Complications of Cirrhosis
- Session Date and Time: Monday, November 18, 2024; 8:00 a.m. – 5:00 p.m. PT
This pooled patient cohort analysis from three Phase 3 studies evaluated the potential impact waiting until Day 4 (and after 12 doses) on HRS reversal in patients treated with TERLIVAZ.5
Poster #4095: The Effect of Obesity on the Clinical Response to Terlipressin in Patients with Hepatorenal Syndrome: Retrospective Assessment from a Pooled Patient Cohort6
- Presenter: Kavish R. Patidar
- Session Type: Poster Presentation
- Session Title: Portal Hypertension and Other Complications of Cirrhosis
- Session Date and Time: Monday, November 18, 2024; 8:00 a.m. – 5:00 p.m. PT
This pooled analysis of data from two Phase 3 studies assessed the potential effect of BMI and corrected BMI (adjusted for the presence of ascites) on the incidence of HRS reversal in patients treated with TERLIVAZ.6
Poster #4096: Role of High Versus Standard Dose of Terlipressin in Reversing HRS-AKI: Pooled Analysis from Phase 3 Clinical Trials7
- Presenter: Pratima Sharma
- Session Type: Poster Presentation
- Session Title: Portal Hypertension and Other Complications of Cirrhosis
- Session Date and Time: Monday, November 18, 2024; 8:00 a.m. – 5:00 p.m. PT
This pooled analysis of data from three Phase 3 studies assessed the efficacy and safety of TERLIVAZ in patients who received a standard or high (escalated) dose.7
Poster #4092: The impact of terlipressin treatment on liver transplantation rates in patients with hepatorenal syndrome-acute kidney injury (HRS-AKI) in the context of the changing MELD score definitions8
- Presenter: Pierre M. Gholam
- Session Type: Poster Presentation
- Session Title: Portal Hypertension and Other Complications of Cirrhosis
- Session Date and Time: Monday, November 18, 2024; 8:00 a.m. – 5:00 p.m. PT
This analysis showed rates of HRS reversal and liver transplant among a subpopulation of patients treated with TERLIVAZ and reported on changes of MELD scores in patients who would be eligible for treatment per
These analyses were sponsored by Mallinckrodt Pharmaceuticals.
INDICATION AND LIMITATION OF USE
TERLIVAZ is indicated to improve kidney function in adults with hepatorenal syndrome with rapid reduction in kidney function.
- Patients with a serum creatinine >5 mg/dL are unlikely to experience benefit.
IMPORTANT SAFETY INFORMATION
WARNING: SERIOUS OR FATAL RESPIRATORY FAILURE
- TERLIVAZ may cause serious or fatal respiratory failure. Patients with volume overload or with acute-on-chronic liver failure (ACLF) Grade 3 are at increased risk. Assess oxygenation saturation (e.g., SpO2) before initiating TERLIVAZ.
- Do not initiate TERLIVAZ in patients experiencing hypoxia (e.g., SpO2 <
90% ) until oxygenation levels improve. Monitor patients for hypoxia using continuous pulse oximetry during treatment and discontinue TERLIVAZ if SpO2 decreases below90% .
Contraindications
TERLIVAZ is contraindicated:
- In patients experiencing hypoxia or worsening respiratory symptoms.
- In patients with ongoing coronary, peripheral, or mesenteric ischemia.
Warnings and Precautions
- Serious or Fatal Respiratory Failure: Obtain baseline oxygen saturation and do not initiate TERLIVAZ in hypoxic patients. Monitor patients for changes in respiratory status using continuous pulse oximetry and regular clinical assessments. Discontinue TERLIVAZ in patients experiencing hypoxia or increased respiratory symptoms.
Manage intravascular volume overload by reducing or discontinuing the administration of albumin and/or other fluids and through judicious use of diuretics. Temporarily interrupt, reduce, or discontinue TERLIVAZ treatment until patient volume status improves. Avoid use in patients with ACLF Grade 3 because they are at significant risk for respiratory failure.
- 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.
- Ischemic Events: TERLIVAZ may cause cardiac, cerebrovascular, peripheral, or mesenteric ischemia. Avoid use of TERLIVAZ in patients with a history of severe cardiovascular conditions or cerebrovascular or ischemic disease. Discontinue TERLIVAZ in patients who experience signs or symptoms suggestive of ischemic adverse reactions.
- Embryo-Fetal Toxicity: TERLIVAZ may cause fetal harm when administered to a pregnant woman. If TERLIVAZ is used during pregnancy, the patient should be informed of the potential risk to the fetus.
Adverse Reactions
- The most common adverse reactions (≥
10% ) include abdominal pain, nausea, respiratory failure, diarrhea, and dyspnea.
Please click here to see full Prescribing Information, including Boxed Warning.
ABOUT HEPATORENAL SYNDROME (HRS)
Hepatorenal syndrome (HRS) involving rapid reduction in kidney function1 is an acute and life-threatening condition that occurs in people with advanced liver disease.2 HRS is classified into two distinct types – a rapidly progressive type that leads to acute renal failure where patients are typically hospitalized for their care and a more chronic type that progresses over weeks to months.2 HRS involving rapid reduction in kidney function1 is estimated to affect more than 42,000 Americans annually, approximately
ABOUT MALLINCKRODT
Mallinckrodt is a global business consisting of multiple wholly owned subsidiaries that develop, manufacture, market and distribute specialty pharmaceutical products and therapies. The company's Specialty Brands reportable segment's areas of focus include autoimmune and rare diseases in specialty areas like neurology, rheumatology, hepatology, nephrology, pulmonology, ophthalmology, and oncology; immunotherapy and neonatal respiratory critical care therapies; analgesics; and gastrointestinal products. Its Specialty Generics reportable segment includes specialty generic drugs and active pharmaceutical ingredients. To learn more about Mallinckrodt, visit www.mallinckrodt.com.
CAUTIONARY STATEMENTS RELATED TO FORWARD-LOOKING STATEMENTS
This release contains forward-looking statements, including with regard to TERLIVAZ®, its potential to improve health and treatment outcomes, and its potential impact on patients. The statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: the effects of Mallinckrodt's recent emergence from bankruptcy; satisfaction of, and compliance with, regulatory and other requirements; actions of regulatory bodies and other governmental authorities; changes in laws and regulations; issues with product quality, manufacturing or supply, or patient safety issues or adverse side effects or adverse reactions associated with TERLIVAZ; and other risks identified and described in more detail in the "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Mallinckrodt's most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and other filings with the SEC, all of which are available on its website. The forward-looking statements made herein speak only as of the date hereof and Mallinckrodt does not assume any obligation to update or revise any forward-looking statement, whether as a result of new information, future events and developments or otherwise, except as required by law.
CONTACT
Media Inquiries
Green Room Communications
908-577-4531
mediainquiries@grcomms.com
Investor Relations
Derek Belz
Vice President, Investor Relations
314-654-3950
derek.belz@mnk.com
Mallinckrodt, the "M" brand mark, TERLIVAZ, and the Mallinckrodt Pharmaceuticals logo are trademarks of a Mallinckrodt company. Other brands are trademarks of a Mallinckrodt company or their respective owners.
©2024 Mallinckrodt. US-2400776 10/24
References
1 TERLIVAZ® (terlipressin) for Injection. Prescribing Information. Mallinckrodt Hospital Products Inc. 2023.
2 National Organization for Rare Disorders. Hepatorenal Syndrome. Available at: https://rarediseases.org/rare-diseases/hepatorenal-syndrome/. Accessed October 2024.
3 United States Census Bureau: Quick Facts. Available at: https://www.census.gov/quickfacts/fact/table/US/PST045218. Accessed October 2024.
4 Singh J., Dahiya D.S., Kichloo A., et al. Hepatorenal Syndrome: A Nationwide Trend Analysis from 2008 to 2018. Annals of Med. 2021;53:1. 2018-2024 doi.org/10/1080/07853890.
5 Izzy, M.J., Gonzalez, S.A., Jalal, P.K., and Cardoza, S. Patience is a Virtue: Evidence for Waiting Until Day 4 and After 12 Doses of Terlipressin Before Evaluating Treatment Response in Patients with HRS-AKI. Abstract to be presented in a poster presentation at the American Association for the Study of Liver Diseases – The Liver Week Meeting. November 2024.
6 Patidar, K.R., Allegretti, A.S., Cullaro, G., et al. The Effect of Obesity on the Clinical Response to Terlipressin in Patients with Hepatorenal Syndrome: Retrospective Assessment from a Pooled Patient Cohort. Abstract to be presented in a poster presentation at the American Association for the Study of Liver Diseases – The Liver Week Meeting. November 2024.
7 Sharma, P., Lim, N., Kwong, A.J., et al. Role of High Versus Standard Dose of Terlipressin in Reversing HRS-AKI: Pooled Analysis from Phase 3 Clinical Trials. Abstract to be presented in a poster presentation at the American Association for the Study of Liver Diseases – The Liver Week Meeting. November 2024.
8Gholam, P.M., Gordon, S.C., Jesudian, A.B., et al. The impact of terlipressin treatment on liver transplantation rates in patients with hepatorenal syndrome-acute kidney injury (HRS-AKI) in the context of the changing MELD score definitions. Abstract to be presented in a poster presentation at the American Association for the Study of Liver Diseases – The Liver Week Meeting. November 2024.
9Flamm, S.L., Brown, K., Wadei, H.M., et al. The Current Management of Hepatorenal Syndrome–Acute Kidney Injury in
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FAQ
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