Mallinckrodt Presents Information on TERLIVAZ ® (terlipressin) for Injection in Sufferers with Hepatorenal Syndrome (HRS) at Kidney Week 2024 By Investing.com

“ Pooled evaluation from Part 3 scientific trials highlights liver transplant charges in grownup sufferers with HRS with speedy discount in kidney perform handled with TERLIVAZ¹  “

DUBLIN, Oct. 26, 2024 /PRNewswire/ —  Mallinckrodt plc, a worldwide specialty pharmaceutical firm, at this time introduced a poster presentation on TERLIVAZ ^® (terlipressin) for injection in sufferers with hepatorenal syndrome (HRS) with speedy discount in kidney perform¹ at Kidney Week 2024, the annual assembly of the American Society of Nephrology (ASN) going down in San Diego from October 23-27, 2024.

TERLIVAZ is the primary and solely FDA-approved product indicated to enhance kidney perform in adults with HRS with speedy discount in kidney perform,¹ an acute and life-threatening situation requiring hospitalization.² HRS involving speedy discount in kidney perform¹ is estimated to have an effect on greater than 42,000 People yearly, roughly 0.01% of the U.S. inhabitants,³ making it a really uncommon situation; and charges of hospitalizations are growing.⁴

Please see Limitation of Use and Necessary Security Data, together with Boxed Warning, beneath.

The poster presentation highlights a pooled evaluation of information from the CONFIRM and REVERSE Part 3 placebo-controlled trials of TERLIVAZ.⁵ The evaluation examined the charges of hepatorenal syndrome-acute kidney harm (HRS-AKI) reversal, renal alternative remedy (RRT), and liver transplant (LT) amongst a subpopulation of sufferers listed for LT at baseline who met FDA label pointers for therapy with TERLIVAZ (SCr 5 On this affected person subpopulation, therapy with TERLIVAZ elevated the speed of HRS-AKI reversal and decreased the necessity for RRT in any respect time factors assessed.⁵ The rise in HRS-AKI reversal with TERLIVAZ didn’t negatively affect the LT fee in sufferers listed for LT at baseline.⁵  

• The speed of HRS-AKI reversal was 43% within the TERLIVAZ group (n=53) and 20% within the placebo group (n=35).⁵
• The speed of RRT within the TERLIVAZ and placebo teams was 28% and 46% by Day 30; 32% and 54% by Day 60; and 36% and 54% by Day 90, respectively.⁵
• The LT fee was related within the TERLIVAZ and placebo teams in any respect time factors assessed: 53% and 51% by Day 30; 66% and 57% by Day 60; and 66% and 63% by Day 90, respectively.⁵

The constraints of this examine embody, however aren’t restricted to, small pattern sizes, variables in methodology, and potential errors and omissions inside the knowledge units.⁵

“This analysis of data from our Phase 3 trials furthers our understanding of the appropriate patient subpopulations and the potential impact of treatment on liver transplantation rates,” mentioned Peter Richardson, MRCP (UK), Government Vice President & Chief Scientific Officer. “For these critically ill patients with HRS-AKI, a liver transplant is the definitive treatment, and we know there are significant challenges associated with RRT; which makes continued research important.”

This examine was sponsored by Mallinckrodt (OTC:) Prescription drugs. Presentation particulars could be discovered beneath:

Poster #PO0102-2: Hepatorenal syndrome-acute kidney harm reversal and liver transplant charges in sufferers handled with terlipressin⁵

• Presenter: Justin Belcher
• Session Kind: Poster Presentation
• Session AKI: Scientific, Outcomes, and Trials – Administration
• Session Date and Time: Saturday, October 26, 2024; 10:00 a.m. “ 12:00 p.m. PT

INDICATION AND LIMITATION OF USE

TERLIVAZ is indicated to enhance kidney perform in adults with hepatorenal syndrome with speedy discount in kidney perform.

• Sufferers with a serum creatinine >5 mg/dL are unlikely to expertise profit.

IMPORTANT SAFETY INFORMATION

WARNING: SERIOUS OR FATAL RESPIRATORY FAILURE

• TERLIVAZ might trigger severe or deadly respiratory failure. Sufferers with quantity overload or with acute-on-chronic liver failure (ACLF) Grade 3 are at elevated threat. Assess oxygenation saturation (e.g., SpO₂) earlier than initiating TERLIVAZ.

• Don’t provoke TERLIVAZ in sufferers experiencing hypoxia (e.g., SpO₂ 2 decreases beneath 90%.

Contraindications

TERLIVAZ is contraindicated:

• In sufferers experiencing hypoxia or worsening respiratory signs.
• In sufferers with ongoing coronary, peripheral, or mesenteric ischemia.

Warnings and Precautions

• Critical or Deadly Respiratory Failure: Get hold of baseline oxygen saturation and don’t provoke TERLIVAZ in hypoxic sufferers. Monitor sufferers for adjustments in respiratory standing utilizing steady pulse oximetry and common scientific assessments. Discontinue TERLIVAZ in sufferers experiencing hypoxia or elevated respiratory signs.

Handle intravascular quantity overload by lowering or discontinuing the administration of albumin and/or different fluids and thru even handed use of diuretics. Quickly interrupt, cut back, or discontinue TERLIVAZ therapy till affected person quantity standing improves. Keep away from use in sufferers with ACLF Grade 3 as a result of they’re at vital threat for respiratory failure.

• Ineligibility for Liver Transplant: TERLIVAZ-related adversarial reactions (respiratory failure, ischemia) might make a affected person ineligible for liver transplantation, if listed. For sufferers with excessive prioritization for liver transplantation (e.g., MELD ‰¥35), the advantages of TERLIVAZ might not outweigh its dangers.

• Ischemic Occasions: TERLIVAZ might trigger cardiac, cerebrovascular, peripheral, or mesenteric ischemia. Keep away from use of TERLIVAZ in sufferers with a historical past of extreme cardiovascular circumstances or cerebrovascular or ischemic illness. Discontinue TERLIVAZ in sufferers who expertise indicators or signs suggestive of ischemic adversarial reactions.

• Embryo-Fetal Toxicity: TERLIVAZ might trigger fetal hurt when administered to a pregnant lady. If TERLIVAZ is used throughout being pregnant, the affected person must be knowledgeable of the potential threat to the fetus.

Opposed Reactions

• The most typical adversarial reactions ( ‰¥10%) embody stomach ache, nausea, respiratory failure, diarrhea, and dyspnea.

Please click on right here to see full Prescribing Data, together with Boxed Warning.

ABOUT HEPATORENAL SYNDROME (HRS)
Hepatorenal syndrome (HRS) involving speedy discount in kidney perform¹ is an acute and life-threatening situation that happens in individuals with superior liver illness.² HRS is classed into two distinct varieties “ a quickly progressive sort that results in acute renal failure the place sufferers are usually hospitalized for his or her care and a extra persistent sort that progresses over weeks to months.²  HRS involving speedy discount in kidney perform¹ is estimated to have an effect on greater than 42,000 People yearly, roughly 0.01% of the U.S. inhabitants,³ making it a really uncommon situation; and charges of HRS hospitalizations are growing.⁴ If left untreated, HRS with speedy discount in kidney perform¹ has a median survival time of lower than two weeks and better than 80 p.c mortality inside three months.⁶

ABOUT  MALLINCKRODT
Mallinckrodt is a worldwide enterprise consisting of a number of wholly owned subsidiaries that develop, manufacture, market and distribute specialty pharmaceutical merchandise and therapies. The corporate’s Specialty Manufacturers reportable phase’s areas of focus embody autoimmune and uncommon ailments in specialty areas like neurology, rheumatology, hepatology, nephrology, pulmonology, ophthalmology, and oncology; immunotherapy and neonatal respiratory essential care therapies; analgesics; and gastrointestinal merchandise. Its Specialty Generics reportable phase contains specialty generic medicine and energetic pharmaceutical components. To be taught extra about Mallinckrodt, go to  www.mallinckrodt.com.

CAUTIONARY STATEMENTS RELATED TO FORWARD-LOOKING STATEMENTS
This launch comprises forward-looking statements, together with with regard to TERLIVAZ ^®, its potential to enhance well being and therapy outcomes, and its potential affect on sufferers. The statements are primarily based on assumptions about many essential elements, together with the next, which might trigger precise outcomes to vary materially from these within the forward-looking statements: the consequences of Mallinckrodt’s current emergence from chapter; satisfaction of, and compliance with, regulatory and different necessities; actions of regulatory our bodies and different governmental authorities; adjustments in legal guidelines and laws; points with product high quality, manufacturing or provide, or affected person issues of safety or adversarial unwanted effects or adversarial reactions related to TERLIVAZ; and different dangers recognized and described in additional element within the “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of Mallinckrodt’s most up-to-date Annual Report on Type 10-Ok, Quarterly Experiences on Type 10-Q, and different filings with the SEC, all of which can be found on its web site. The forward-looking statements made herein converse solely as of the date hereof and Mallinckrodt doesn’t assume any obligation to replace or revise any forward-looking assertion, whether or not on account of new data, future occasions and developments or in any other case, besides as required by regulation.

CONTACT

Media Inquiries
Inexperienced Room Communications
908-577-4531
mediainquiries@grcomms.com

Investor Relations
Derek BelzVice President, Investor Relations
314-654-3950
derek.belz@mnk.com

Mallinckrodt, the “M” model mark, TERLIVAZ, and the  Mallinckrodt Prescription drugs  emblem are logos of a  Mallinckrodt  firm. Different manufacturers are logos of a  Mallinckrodt  firm or their respective homeowners.

©2024 Mallinckrodt. US-2400773  10/24

References

¹ TERLIVAZ ^® (terlipressin) for Injection. Prescribing Data. Mallinckrodt Hospital Merchandise Inc. 2023.
² Nationwide Group for Uncommon Problems. Hepatorenal Syndrome. Obtainable at: https://rarediseases.org/rare-diseases/hepatorenal-syndrome/. Accessed October 2024.
³ United States Census Bureau: Fast Details. Obtainable at: https://www.census.gov/quickfacts/reality/desk/US/PST045218. Accessed October 2024.
⁴ Singh J., Dahiya D.S., Kichloo A., et al. Hepatorenal Syndrome: A Nationwide Pattern Evaluation from 2008 to 2018. Annals of Med. 2021;53:1. 2018-2024 doi.org/10/1080/07853890.
⁵ Belcher J.M., Regner Ok.R., Mujtaba M.A., et al. Hepatorenal syndrome-acute kidney harm reversal and liver transplant charges in sufferers handled with terlipressin. Summary to be introduced on the  American Society of Nephrology  (ASN) 2024 Annual assembly. October 2024.
⁶ Flamm, S.L., Brown, Ok., Wadei, H.M., et al. The Present Administration of Hepatorenal Syndrome“Acute Kidney Damage in the US and the Potential of Terlipressin. Liver Transpl. 2021;27:1191-1202. https://doi.org/10.1002/lt.26072.