Mallinckrodt Announces U.S. Food and Drug Administration (FDA) Advisory Committee Voted to Recommend Terlipressin for Approval to Treat Patients with Hepatorenal Syndrome Type 1 (HRS-1)
"Mallinckrodt is pleased with the advisory committee's positive vote in favor of approval for terlipressin, supporting the potential clinical value terlipressin can bring to patients with HRS-1 in need of an approved therapy in the
HRS-1 requires a diagnosis of exclusion, and is often a challenge to diagnose in a timely manner.2 If left untreated, HRS-1 has a median survival time of approximately two weeks and greater than 80 percent mortality within three months.2,3 At present, there are no approved drug therapies for HRS-1 in the
"Terlipressin plus albumin is the recommended standard-of-care therapy for HRS-1 in many other countries, where terlipressin is approved," said
While recommendations of the advisory committee are not binding, the FDA will consider the advice provided by the committee as part of the New Drug Application (NDA) review. The FDA assigned terlipressin a Prescription Drug User Fee Act (PDUFA) target date of September 12, 2020. The company announced the FDA accepted for review its NDA for terlipressin in
Terlipressin is a potent vasopressin analogue selective for V1 receptors being investigated for the treatment of HRS-1 in the
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CAUTIONARY STATEMENTS RELATED TO FORWARD-LOOKING STATEMENTS
This release includes forward-looking statements with regard to terlipressin, including the regulatory review process and related timing, as well as 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: 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.
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1 National Organization for Rare Disorders. Hepatorenal Syndrome. Available at: https://rarediseases.org/rare-diseases/hepatorenal-syndrome/. Accessed
2 Gines P, Sola E, Angeli P, et al. Hepatorenal syndrome. Nature Reviews. (2018) 4:23.
3 Colle I and Laterre PF. Hepatorenal syndrome: the clinical impact of vasoactive therapy, Expert Review of Gastroenterology & Hepatology. (2018) 12:2, 173-188, DOI: 10.1080/17474124.2018.1417034.
4 Boyer TD, Medicis JJ, Pappas SC, et al. A randomized, placebo-controlled, double-blind study to confirm the reversal of hepatorenal syndrome type 1 with terlipressin: the REVERSE trial design.
5 C Pant, B S Jani, M Desai, A Deshpande,
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