Mallinckrodt Pharmaceuticals issued the following announcement on July 7.
Mallinckrodt plc (NYSE: MNK), a global biopharmaceutical company, today announced that the Cardiovascular and Renal Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) will, as expected, hold a virtual meeting to review data on terlipressin, an investigational agent being evaluated for the treatment of hepatorenal syndrome type 1 (HRS-1). The company announced the FDA accepted for review its New Drug Application (NDA) for terlipressin in April.
HRS-1 is an acute and life-threatening syndrome involving acute kidney failure in people with cirrhosis.1 The condition has a median survival time of approximately two weeks and greater than 80 percent mortality within three months if left untreated.2,3 At present, there are no approved drug therapies for HRS-1 in the U.S.,4 and it is estimated to affect between 30,000 and 40,000 patients in the U.S. annually.5,6
"We look forward to engaging the advisory committee panel in a robust discussion of the clinical evidence to support the safety and efficacy profile of terlipressin," said Steven Romano, M.D., Executive Vice President and Chief Scientific Officer at Mallinckrodt. "And we are extremely grateful to all the patients and healthcare professionals who made the data collection possible. If approved, we believe terlipressin has the potential to address a critical unmet need in HRS-1."
The terlipressin NDA is based, in part, on results from the Phase 3 CONFIRM trial, which was the largest-ever prospective study (n=300) conducted in patients with HRS-1, and the culmination of a sustained, 17-year effort to develop terlipressin for potential use in the U.S. and Canada. Initial results were presented at The Liver Meeting® 2019, the annual meeting of the American Association for the Study of Liver Diseases (AASLD).
About Terlipressin
Terlipressin is a potent vasopressin analogue selective for V1 receptors being investigated for the treatment of HRS-1 in the U.S. and Canada. It is an investigational product in these countries as the safety and efficacy have not been established with, nor has approval been granted by, regulatory authorities in either country. Terlipressin is approved for use outside the U.S. and Canada.
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.
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