Press release
Arrowhead Pharmaceuticals Announces Health Canada Approval of REDEMPLO™ (plozasiran) to Reduce Triglycerides in Adults with Familial Chylomicronemia Syndrome (FCS)
– REDEMPLO is the first and only Health Canada-approved siRNA medicine to be studied in patients with genetically confirmed and clinically diagnosed FCS –
About this update from Arrowhead Pharmaceuticals, Inc.
[{"type":"text","content":"\n– REDEMPLO is the first and only Health Canada-approved siRNA medicine to be studied in patients with genetically confirmed and clinically diagnosed FCS\n\n\n– People living with FCS have extremely high triglyceride levels and a substantially higher risk of acute pancreatitis and related long-term complications, often resulting in a reduced quality of life\n\n\n– The Health Canada approval is based on positive results from the Phase 3 PALISADE study where REDEMPLO significantly reduced triglycerides from baseline and lowered the numerical incidence of acute pancreatitis compared to placebo\n\n\n PASADENA, Calif.--(BUSINESS WIRE)--\nArrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced that Health Canada has issued a Notice of Compliance (NOC) authorizing REDEMPLO™ (plozasiran), a small interfering RNA (siRNA) medicine, as an adjunct to diet to reduce triglycerides in adults with familial chylomicronemia syndrome (FCS) for whom standard triglyceride lowering therapies have been inadequate. FCS is a severe, rare disease characterized by triglyceride levels that can be 10 to 100 times higher than normal, leading to a substantially higher risk of developing acute, recurrent, and potentially fatal pancreatitis. FCS remains widely underdiagnosed and is estimated to affect between 1 and 13 people per million globally, though is approximately 100 times more common in parts of French Canada. REDEMPLO is the first and only Health Canada-approved siRNA medicine for people living with FCS that can be self-administered at home with a subcutaneous injection once every three months. Today’s authorization follows the recent approval of REDEMPLO in the United States, as Arrowhead continues its efforts to increase global access to care for people living with FCS.\n\n\n“We are thrilled to start the new year with Health Canada’s approval of REDEMPLO as a new treatment option for Canadians living with genetic or clinical FCS,” said Christopher Anzalone, Ph.D., President and CEO of Arrowhead Pharmaceuticals. “Arrowhead continues to drive RNAi innovation with our TRiM™ platform, which is now capable of delivering siRNA to multiple cell types throughout the body and potentially treat a growing array of diseases. As we expand our commercial capabilities, we aim to bring these new treatments to the patients who need them.\"\n\n\nHarnessing Arr...