GSK receives breakthrough status for new monthly liver disease drug
葛蘭素史克（GSK）的新型月服肝病藥物獲「突破性治療」認定
In April 2026, GSK reached a significant milestone in medical research as their investigational drug, efimosfermin, received Breakthrough Therapy Designation from the FDA and PRIME status from the EMA.
2026年4月，葛蘭素史克（GSK）在醫學研究上達到了重要的里程碑。
This regulatory support aims to speed up the development of a potential new treatment for Metabolic Dysfunction-Associated Steatohepatitis (MASH), a serious liver condition that affects about 5% of the global population.
他們的試驗性藥物efimosfermin獲得了美國食品藥物管理局（FDA）的突破性治療認定，以及歐洲藥品管理局（EMA）的優先藥物（PRIME）資格。
MASH is a progressive disease that causes liver inflammation and scarring, or fibrosis, often leading to liver failure or cancer.
這些法規上的支持旨在加速研發一種潛在的新療法，用以治療代謝功能障礙相關脂肪性肝炎（MASH），這是一種影響全球約5%人口的嚴重肝臟疾病。
By regulating metabolic pathways, it helps reduce liver fat and reverse fibrosis.
Efimosfermin是一種長效型的纖維母細胞生長因子21（FGF21）變體。
Notably, it is designed as a convenient once-monthly subcutaneous injection.
透過調節代謝途徑，它有助於減少肝臟脂肪並逆轉纖維化。
Positive Phase II clinical trial data showed that the drug significantly improved fibrosis and resolved MASH, with only mild side effects reported.
值得注意的是，它設計為方便的每月一次皮下注射。
The drug is currently in Phase III trials, known as ZENITH-1 and ZENITH-2, marking a promising step forward for patients suffering from moderate-to-advanced liver fibrosis who are waiting for effective therapies.
第二期臨床試驗的正面數據顯示，該藥物顯著改善了纖維化並緩解了MASH，且僅回報了輕微的副作用。
