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...
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...
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
吉利德科學表示，歐洲藥品管理局人用藥品委員會推薦使用Seladelpar聯合烏反德酸（UDCA）治療對單獨使用UDCA反應不足的成人原發性膽汁性膽管炎，或在無法耐受UDCA的情況下單獨使用。
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.
最終的歐洲委員會決定預計將在2025年第一季度做出。這是繼2024年8月美國食品藥品監督管理局（FDA）加速批准後進行的。
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.
原發性膽汁性膽管炎（PBC）是一種罕見的慢性自身免疫性疾病，影響約每10萬名歐洲人中有15人，主要是女性，如果不治療，會導致肝臟損傷和可能的肝衰竭。PBC最常見的症狀是瘙癢（慢性癢）和疲勞，這可能會使一些人倍感痛苦。目前該疾病沒有治癒的方法，生活在PBC患者的治療目標包括抑制肝臟損傷和減輕與膽汁淤積相關的症狀。治療對減緩疾病進展的效果主要通過肝臟生化測試的改善來衡量，包括鹼性磷酸酶（ALP）水平的正常化，這是一種PBC疾病進展的重要指標。
譯文內容由第三人軟體翻譯。
