Gilead Sciences Says Committee For Medicinal Products For Human Use Of European Medicines Agency Recommends Seladelpar For Treatment Of Primary Biliary Cholangitis In Combination With Ursodeoxycholic Acid (UDCA) In Adults With Inadequate Response To UDCA Alone, Or As Monotherapy In Those Unable To Tolerate UDCA
The final European Commission decision is anticipated in the first quarter of 2025. This follows the accelerated approval by the U.S. Food and Drug Administration (FDA) in August 2024.
PBC is a rare, chronic, autoimmune disease of the bile ducts that affects approximately 15 per 100,000 people in Europe, primarily women, and can cause liver damage and possible liver failure if untreated. The most common symptoms of PBC are pruritus (chronic itch) and fatigue, which can be debilitating for some people. The disease currently has no cure and treatment goals for people living with PBC include suppressing liver damage and reducing the symptoms related to cholestasis. The effect of treatment on slowing disease progression is primarily measured by an improvement in liver biochemical tests, including the normalization of alkaline phosphatase (ALP) levels, an important marker of disease progression in PBC.