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LYVDELZI® (SELADELPAR) RECEIVES HEALTH CANADA APPROVAL FOR THE TREATMENT OF PRIMARY BILIARY CHOLANGITIS
Gilead Sciences, Inc. (Nasdaq: GILD) today announced that Health Canada has approved LYVDELZI (seladelpar) for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have had an inadequate response to UDCA alone, or as monotherapy in patients unable to tolerate UDCA. This market authorization has been issued with conditions pending the results of trials to verify its clinical benefit.
About this update from Gilead Sciences, Inc.
[{"type":"text","content":"– LYVDELZI is the Only Medicine to Demonstrate Statistically Significant and Durable Improvements in Both Pruritus and Markers of Cholestasis Related to the Risk of Disease Progression in a Phase 3 Trial – ","length":210,"tagName":"p","attribs":{}},{"type":"text","content":"– LYVDELZI Expands Gilead's Long-Standing Commitment to People Living with Liver Disease –","length":94,"tagName":"p","attribs":{}},{"type":"text","content":"MISSISSAUGA, ON, Oct. 21, 2025 /CNW/ - Gilead Sciences, Inc. (Nasdaq: GILD) today announced that Health Canada has approved LYVDELZI (seladelpar) for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have had an inadequate response to UDCA alone, or as monotherapy in patients unable to tolerate UDCA. This market authorization has been issued with conditions pending the results of trials to verify its clinical benefit.","length":489,"tagName":"p"},{"type":"image","alt":"Gilead Logo (CNW Group/Gilead Sciences, Inc.)","displaySize":"","headline":null,"caption":"Gilead Logo (CNW Group/Gilead Sciences, Inc.)","className":"","disableSlideshowImg":false,"size":{"original":{"width":400,"height":115,"url":"https://media.zenfs.com/en/cnwgroup.com/bfd06ddaa68caa18c24b592189e9a993"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/I_NshlJld4ipz_HWFtVGGg--/YXBwaWQ9aGlnaGxhbmRlcjt3PTcwNTtoPTIwMztjZj13ZWJw/https://media.zenfs.com/en/cnwgroup.com/bfd06ddaa68caa18c24b592189e9a993","width":400,"height":115}},"href":"https://mma.prnewswire.com/media/2799512/Gilead_Sciences__Inc__LYVDELZI_%C2%A0_SELADELPAR__RECEIVES_HEALTH_CAN.html","hrefExternal":true,"rel":"nofollow"},{"type":"text","content":"PBC is a rare, chronic autoimmune liver disease that progressively destroys the liver's bile ducts and can lead to fibrosis, cirrhosis, liver failure, liver cancer and, in some cases, liver-related mortality.1 The condition affects approximately 13,000 Canadians, most of whom are women over the age of 40.1,2 For those living with PBC, common symptoms such as itch (pruritus) and fatigue can severely affect day-to-day life and overall well-being.3","length":458,"tagName":"p"},{"type":"text","content":"While ursodeoxycholic acid (UDCA) remains the standard first-line therapy, up to 40% of people living with PBC have an inadequate response or cannot tole...