{"id":1675,"date":"2025-04-28T14:16:27","date_gmt":"2025-04-28T12:16:27","guid":{"rendered":"https:\/\/www.ipsen.com\/canada\/?post_type=press_release&p=1675"},"modified":"2025-07-01T03:21:47","modified_gmt":"2025-07-01T01:21:47","slug":"health-canada-approves-iqirvo-as-a-first-in-class-dual-peroxisome-proliferator-activated-receptor-treatment-for-primary-biliary-cholangitis","status":"publish","type":"press_release","link":"https:\/\/www.ipsen.com\/canada\/press-releases\/health-canada-approves-iqirvo-as-a-first-in-class-dual-peroxisome-proliferator-activated-receptor-treatment-for-primary-biliary-cholangitis\/","title":{"rendered":"Health Canada approves IQIRVO\u00ae as a first-in-class dual-peroxisome proliferator-activated receptor treatment for primary biliary cholangitis"},"content":{"rendered":"\n

IQIRVO\u00ae<\/sup> (elafibranor) is the first new medicine approved in nearly a decade for the treatment of rare cholestatic liver disease Primary Biliary Cholangitis<\/em><\/em><\/p>\n\n\n\n

Mississauga, ON \u2013 April 28, 2025<\/strong> \u2013 Ipsen Biopharmaceuticals Canada Inc. today announced Health Canada has issued a Notice of Compliance with Conditions (NOC\/c) approving IQIRVO\u00ae<\/sup> (elafibranor) for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA, or as monotherapy in adults unable to tolerate UDCA.1<\/sup><\/p>\n\n\n\n

PBC is a chronic, rare autoimmune liver disease where the immune system attacks the liver causing slow, progressive damage to the bile ducts.2,3<\/sup> Canada has one of the highest rates of PBC incidence and prevalence worldwide, affecting 318 individuals for every million Canadians (approximately 13,000 people).4,5<\/sup> PBC is a lifelong condition that can worsen over time if not effectively treated, leading to liver transplant and in some cases, premature death.6<\/sup> <\/p>\n\n\n\n

\u201cThe treatment landscape for PBC has not seen advancement in nearly a decade, making IQIRVO\u00ae<\/sup> <\/sup>a significant step forward in filling an unmet need for Canadian patients,\u201d said Dr. Mark G. Swain, Professor of Medicine, Cal Wenzel Family Foundation Chair in Hepatology. \u201cIf left untreated, PBC can progress and lead to liver failure, which is why second line options are needed. Based on the Phase III ELATIVE\u00ae<\/sup> trial, IQIRVO\u00ae<\/sup> offers the potential to significantly reduce serum ALP levels, providing patients with an effective second line treatment option.\u201d<\/p>\n\n\n\n

IQIRVO\u00ae<\/sup> is a first-in-class oral, once-daily peroxisome proliferator-activated receptor (PPAR) agonist. The accelerated approval by Health Canada was based on data from ELATIVE\u00ae<\/sup> trial, a randomized, placebo-controlled, phase III study that assessed alkaline phosphatase (ALP) and bilirubin as a composite biochemical surrogate endpoint.7<\/sup> In the study, IQIRVO\u00ae<\/sup> demonstrated a statistically significant treatment benefit with 51% of patients on IQIRVO\u00ae<\/sup> achieving a biochemical response compared with 4% on the placebo arm for a 47% treatment difference regardless of baseline ALP.8<\/sup> Biochemical response was defined as ALP less than 1.67 Upper Limit of Normal (ULN), an ALP decrease of greater than or equal to 15% from baseline and total bilirubin (TB) \u2264 ULN at week 52.9<\/sup><\/p>\n\n\n\n

\u201cPBC is a rare, slowly progressive autoimmune liver disease and because it is somewhat \u2018invisible\u2019 it may be misunderstood and dismissed by friends, family and even the medical community,\u201d said Gail Wright, President of Canadian PBC Society. \u201cThe impact of PBC on day-to-day life can be devastating, especially for those PBC patients that suffer from severe fatigue and debilitating itch. Unrelenting symptoms affect their ability to work and carry out tasks of daily living, which can result in social isolation, anxiety and depression. The Canadian PBC Society welcomes this approval underscoring the importance of having access to well-tolerated and effective treatment options for Canadians living with PBC that potentially slow disease progression.\u201d<\/p>\n\n\n\n

PBC is the most common autoimmune liver disease, primarily affecting women aged 35-60, and impacting 1 in 1,000 women over the age of 40.10<\/sup> Men are also susceptible but to a much lesser degree, with a ratio of one affected man for every nine affected women.11<\/sup><\/p>\n\n\n\n

\u201cFor many people living with PBC, the existing treatment does not control the condition,\u201d said Ed Dybka, General Manager, Ipsen Biopharmaceuticals Canada Inc. \u201cIQIRVO\u00ae<\/sup> is a first-in-class treatment and this approval underscores Ipsen\u2019s commitment to being a leader in developing innovations that address unmet needs for Canadians living with rare disease.\u201d<\/p>\n\n\n\n

About the Phase III ELATIVE<\/strong>\u00ae<\/strong><\/sup> Trial<\/strong>12<\/strong><\/sup><\/p>\n\n\n\n

The ELATIVE\u00ae<\/sup> trial is a multi-centre, randomized double-blind, placebo-controlled Phase III clinical trial (n=161) that evaluated the efficacy and safety of IQIRVO\u00ae<\/sup> 80mg once daily plus UDCA (n=108) versus placebo plus UDCA (n=53<\/a>). IQIRVO\u00ae<\/sup> or placebo was administered in combination with UDCA in 95% of patients and as monotherapy in 5% of patients who were unable to tolerate UDCA. The 52-week study was completed by 92% of participants with 97% of those who completed the study continuing in an extension study. The results were published in the New England Journal of Medicine.<\/em>13<\/sup><\/p>\n\n\n\n