PR Newswire
STAINES-UPON-THAMES, United Kingdom, March 5, 2020
STAINES-UPON-THAMES, United Kingdom, March 5, 2020 /PRNewswire/ -- Mallinckrodt plc (NYSE: MNK), a global biopharmaceutical company, today announced publication of findings from a prospective, open-label pilot study to assess the efficacy and safety of Acthar® Gel (repository corticotropin injection) in patients with immunoglobulin A nephropathy (IgAN) at high risk of chronic kidney disease progression.1 The study was published in Kidney International Reports, the journal of the International Society of Nephrology. IgAN, also known as Berger's disease, is a kidney disease that occurs when IgA deposits build up in the kidneys, causing inflammation that damages kidney tissues2,3
The study, titled "An Open-Label Pilot Study of Adrenocorticotrophic Hormone in the Treatment of lgA Nephropathy at High Risk of Progression," demonstrated that treatment with Acthar Gel resulted in a significant reduction in 24-hour urinary protein (P=0.007) with a stable estimated glomerular filtration rate (eGFR) (P=0.1) – a measure of renal function – following six months of treatment with 80 units twice weekly, and an additional six-month follow up. Elevated amounts of urinary protein (>1 g/24 hours) are associated with increased risk of progression to end-stage renal disease and up to 50 percent of patients with IgAN and proteinuria will progress to end-stage renal disease within 15 years.1 No patients discontinued the study due to side effects and there were no serious adverse events reported. Six patients were treated for infections. The most common other adverse events were injection reaction, muscle soreness, acne, hot flashes, anxiety and insomnia.1
Acthar® Gel (repository corticotropin injection) is indicated to induce a diuresis or a remission of proteinuria (excess protein in the urine) in nephrotic syndrome without uremia of the idiopathic type or that due to lupus erythematosus.4 Please see Important Safety Information for Acthar Gel below.
"IgAN is a clinically challenging immune-mediated kidney disease in which patients are at risk of rapidly progressing to end-stage renal disease, yet there are limited therapeutic options for the reduction of proteinuria in IgAN available to physicians and patients," said Tunde Otulana, M.D., Senior Vice President and Chief Medical Officer at Mallinckrodt. "We are encouraged by these results and are committed to supporting additional research in this patient population with unmet needs."
Study Methods1
Key Findings1
Study Limitations1
"Patients with IgAN are at risk of renal failure progressing to end-stage renal disease," said James A. Tumlin, M.D., FASN, Professor of Medicine at Emory University. "There is a great need to identify effective treatment options for these patients, and it's encouraging to see new research in this area of high unmet need."
About IgA Nephropathy
Immunoglobulin A (IgA) nephropathy is one of the most common kidney diseases.2,5 Also known as Berger's disease, IgAN is a kidney disease that occurs when the IgA deposits build up in the kidneys.2 IgA is an antibody produced by the body's immune system.3 Buildup of IgA antibodies results in inflammation that may hamper the kidneys' ability to filter wastes from the blood over time.5 While IgA nephropathy often progresses slowly over many years, the course of the disease can vary in each patient. Some patients may experience blood in their urine without developing problems, some may achieve complete remission, while others develop end-stage kidney failure.3,5 While there is no cure for IgAN, certain medications can slow its course.3,5 IgAN can occur at any age, although the first evidence of kidney disease most frequently appears when people are in their teens to late 30s.3 In the U.S., IgAN is twice as likely to appear in men than in women.3 While found in people all over the world, IgAN is more common among Asians and Caucasians.6
Acthar® Gel (repository corticotropin injection) is indicated for:
IMPORTANT SAFETY INFORMATION
Contraindications
Warnings and Precautions
Adverse Reactions
Other adverse events reported are included in the full Prescribing Information.
Please see full Prescribing Information for additional Important Safety Information.
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, nephrology, pulmonology and ophthalmology; 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.
Mallinckrodt uses its website as a channel of distribution of important company information, such as press releases, investor presentations and other financial information. It also uses its website to expedite public access to time-critical information regarding the company in advance of or in lieu of distributing a press release or a filing with the U.S. Securities and Exchange Commission (SEC) disclosing the same information. Therefore, investors should look to the Investor Relations page of the website for important and time-critical information. Visitors to the website can also register to receive automatic e-mail and other notifications alerting them when new information is made available on the Investor Relations page of the website.
CAUTIONARY STATEMENTS RELATED TO FORWARD-LOOKING STATEMENTS
This release includes forward-looking statements concerning Acthar Gel including its potential impact on patients and anticipated benefits associated with its use. 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: satisfaction of 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; and other risks identified and described in more detail in the "Risk Factors" section of Mallinckrodt's most recent Annual Report on Form 10-K 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.
CONTACTS
For Trade Media Inquiries
Caren Begun
Green Room Communications
201-396-8551
caren@greenroompr.com
For Financial/Dailies Media Inquiries
Jim Heins
H+K Strategies
212-885-0463
jim.heins@hkstrategies.com
Investor Relations
Daniel J. Speciale, CPA
Vice President, Investor Relations and IRO
314-654-3638
daniel.speciale@mnk.com
Mallinckrodt, the "M" brand mark and the Mallinckrodt Pharmaceuticals logo are trademarks of a Mallinckrodt company. Other brands are trademarks of a Mallinckrodt company or their respective owners. ©2020 Mallinckrodt. US-2000135 3/20
References
1 Zand, L, Canetta P, Lafayette R, Aslam N, Jan N, Sethi S, et al. An Open-Label Pilot Study of Adrenocorticotrophic Hormone in the Treatment of IgA Nephropathy at High Risk of Progression. Kidney Int Rep, Volume 5, Issue 1, 58-65. doi: 10.1016/j.ekir.2019.10.007. eCollection 2020 Jan.
2 Schena FP, Nistor I. Epidemiology of IgA Nephropathy: A global perspective. Semin. Nephrol. 2018;38(5): 435–442. doi: 10.1016/j.semnephrol.2018.05.013.
3 Wyatt RJ, Julian BA. IgA Nephropathy. N Engl J Med. 2013;368(25):2402–2414. DOI: 10.1056/NEJMra1206793
4 Acthar® Gel (repository corticotropin injection) [prescribing information]. Mallinckrodt ARD LLC.
5 Lafayette RA, Kelepouris E. Immunoglobulin A nephropathy: advances in understanding of pathogenesis and treatment. Am J Nephrol 2018;47(suppl 1):43–52. doi: 10.1159/000481636.
6 Satpathy HK. IgA Nephropathy. In: Ferri FF, ed. Ferri's Clinical Advisor 2013. 1st ed. St. Louis: Mosby; 2012: 570–571.
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SOURCE Mallinckrodt Pharmaceuticals
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