LYVDELZI® (SELADELPAR) RECEIVES HEALTH CANADA APPROVAL FOR THE TREATMENT OF PRIMARY BILIARY CHOLANGITIS
– 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 –
– LYVDELZI Expands Gilead's Long-Standing Commitment to People Living with Liver Disease –
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.
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
While ursodeoxycholic acid (UDCA) remains the standard first-line therapy, up to 40% of people living with PBC have an inadequate response or cannot tolerate it, leaving them at continued risk of disease progression and persistent symptoms.4
LYVDELZI (seladelpar) offers an important new option for these individuals as a treatment that achieved statistically significant reduction across biochemical response, alkaline phosphatase (ALP) normalization, and pruritus (itch) versus placebo.5
"As a PBC patient and president of the Canadian PBC Society, I welcome the approval of this new treatment." said Gail Wright, President, Canadian PBC Society. "This announcement represents meaningful progress in expanding treatment options and improving our quality of life. Those living with PBC share common symptoms, including incessant itching or skin-crawling sensations, as well as debilitating fatigue that is made worse at night. The availability of a new treatment option that addresses both biochemical markers and helps reduce intense itching is a milestone for our community allowing clinicians to better personalize treatment for people with PBC."
The conditional approval was based primarily on data from the pivotal, placebo-controlled, Phase 3 RESPONSE study. In the study, 62% of participants taking LYVDELZI achieved the primary endpoint of composite biochemical response at month 12, versus 20% of participants taking placebo. Biochemical response was defined as achieving ALP less than 1.67-times the ULN, an ALP decrease of greater than or equal to 15% from baseline, and total bilirubin less than or equal to ULN.6
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. The key secondary endpoint, normalization of alkaline phosphatase at month 12 (ALP; less than or equal to ULN), a cholestatic marker and predictor of risk for liver transplant and death, was achieved in 25% of LYVDELZI-treated patients, versus none in the placebo group. LYVDELZI also met the key secondary endpoint of change from baseline in pruritus score at month 6 by demonstrating a statistically significant and clinically meaningful reduction in pruritus compared with placebo, in patients who already had clinically significant itching before starting treatment. Pruritus (itch) is a common symptom that can significantly impair quality of life in people with PBC.7 The most common adverse events (reported in ≥5% of trial participants in the LYVDELZI arm and higher compared to placebo) were headache, abdominal pain, nausea, abdominal distension (swelling) and dizziness.
"Current therapies have limitations optimally addressing both disease progression and symptom burden," said Dr. Gideon Hirschfield, Director of the Autoimmune and Rare Liver Disease Programme at UHN's Francis Family Liver Clinic, Toronto General Hospital, and lead author of the RESPONSE Trial. "In a rigorous phase 3 trial setting, LYVDELZI was the first PBC medicine to meet both of these critical needs with statistical significance."
"The approval of LYVDELZI marks an important milestone, offering a new choice with a distinct profile that may help address unmet needs," said Paul Petrelli, General Manager, Gilead Sciences Canada. "We're proud to build on Gilead's deep heritage in liver disease and are committed to ensuring Canadian patients who could benefit from LYVDELZI have access to it."
About LYVDELZI
LYVDELZI (seladelpar) is a daily oral, selective PPAR-delta agonist, used to treat PBC in patients with inadequate response or intolerance to UDCA (respectively in combination or as a monotherapy). LYVDELZI works by targeting specific pathways in the liver to reduce inflammation, improve bile flow, and help normalize liver enzymes.
LYVDELZI has potential to help meet the current unmet need of people living with PBC, as a new treatment to achieve statistically significant reduction across biochemical response, alkaline phosphatase (ALP) normalization, and pruritus (itch) versus placebo. Pruritus is a common symptom that can significantly impair quality of life in people with PBC.1
LYVDELZI received a Notice of Compliance with conditions (NOC/c) from Health Canada, requiring Gilead to conduct confirmatory clinical trials and report the outcomes within an established timeframe.
For more safety and prescribing information, please refer to the LYVDELZI product monograph https://www.gilead.com/en-ca/-/media/gilead-canada/pdfs/product-monographs/lyvdelzi_english_pm.pdf.
Canadian Indication for LYVDELZI
LYVDELZI (seladelpar) is indicated 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.
About PBC
PBC is a rare, chronic inflammatory liver disease primarily affecting women (1 in 1,000 women over the age of 40 or approximately 13,000 Canadians).1,2 PBC is characterized by impaired bile flow (known as cholestasis) and the accumulation of toxic bile acids in the liver, leading to inflammation and destruction of the bile ducts within the liver and causing increased levels of alkaline phosphatase (ALP), alanine transaminase (ALT) and gamma-glutamyl transferase (GGT), enzymes found primarily in the liver, as well as total bilirubin.1 The most common symptoms of PBC are pruritus (itch) and fatigue, which can be debilitating for some people.1 Progression of PBC is associated with an increased risk of liver-related mortality.1
About Gilead Sciences in Liver Disease
For decades, Gilead has pioneered the way forward to improve the lives of people living with liver disease around the world. We have helped to transform hepatitis C from a chronic condition into one that can be cured for millions of people. For people living with hepatitis B or D, our focus on advancing our medicines drives hope that today's research will turn into tomorrow's cures. Beyond viral hepatitis, we're working to deliver advanced treatments for people living with PBC. But our commitment doesn't stop there. Through our ground-breaking science and collaborative partnerships, we strive to create healthier futures for everyone living with liver disease. We are committed to a future without liver disease.
About Gilead Sciences
Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, COVID-19 and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California. For more information about our Canadian operations visit https://gilead.ca
LYVDELZI, Gilead, their respective logos, and GSI are trademarks of Gilead Sciences, Inc. and its related companies.
For more information about Gilead Sciences Canada, please visit the company's website at https://www.gilead.ca/, follow Gilead on LinkedIn (@GileadSciencesCanada), or email Gilead Public Affairs at [email protected].
1 EASL Clinical Practice Guidelines: The diagnosis and management of patients with primary biliary cholangitis: https://www.journal-of-hepatology.eu/article/S0168-8278(17)30186-1/fulltext#sec-11 (Accessed Sept 2025)
2 Clinical Characterization of Patients with Primary Biliary Cholangitis: a Report from Multiple Canadian Centres: https://pmc.ncbi.nlm.nih.gov/articles/PMC9473559/ (Accessed Sept 2025)
3 More than just an itch, Smith HT, 2022: https://pbc-society.ca/images/pdf/THU_470_ILC2022.pdf (Accessed Sept 2025)
4 Barba Bernal R, et al.(2023). Turk J Gastroenterol. Management of Primary Biliary Cholangitis: Current Treatment and Future Perspectives. 34(2), 89–100
5 Gilead Sciences Canada, Inc., LYVDELZI, Product Monograph: https://www.gilead.com/en-ca/-/media/gilead-canada/pdfs/product-monographs/lyvdelzi_english_pm.pdf
6 Gilead Sciences Canada, Inc., LYVDELZI, Product Monograph: https://www.gilead.com/en-ca/-/media/gilead-canada/pdfs/product-monographs/lyvdelzi_english_pm.pdf
7 Gilead Sciences Canada, Inc., LYVDELZI, Product Monograph: https://www.gilead.com/en-ca/-/media/gilead-canada/pdfs/product-monographs/lyvdelzi_english_pm.pdf
SOURCE Gilead Sciences, Inc.
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