Health Canada has granted conditional approval for Gilead Sciences’ Lyvdelzi (seladelpar) for adults with primary biliary cholangitis (PBC) who have responded inadequately to ursodeoxycholic acid (UDCA) or cannot tolerate it.
Seladelpar can be used in combination with UDCA or as a monotherapy.
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The authorisation is pending further clinical trial results to confirm its benefit.
Health Canada has issued a notice of compliance with conditions to Lyvdelzi, requiring Gilead to carry out confirmatory studies and submit the data within a specified timeframe.
PBC is a chronic autoimmune liver disease that destroys the liver’s bile ducts, resulting in cancer, liver failure, cirrhosis and fibrosis.
While UDCA is the standard first-line PBC therapy, up to 40% of patients do not respond to or cannot tolerate it.
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By GlobalDataSeladelpar provides a new option for such individuals, achieving statistically significant improvements in pruritus (itching), biochemical responses and alkaline phosphatase (ALP) normalisation compared to placebo.
Gilead Sciences Canada general manager Paul Petrelli stated: “The approval of Lyvdelzi marks an important milestone, offering a new choice with a distinct profile that may help address unmet needs.
“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.”
The approval is based on the Phase III RESPONSE study data. 62% of seladelpar patients achieved the primary goal of composite biochemical response at month 12 versus 20% for placebo.
The most common adverse events were dizziness, abdominal distension, nausea, abdominal pain and headache.
In July 2025, the World Health Organization recommended the use of Gilead’s injectable version of lenacapavir to treat HIV.
