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Madrigal Pharmaceuticals Announces Publication Of Health-Related Quality Of Life Results From The Phase 3 MAESTRO-NASH Trial Of Rezdiffra

Madrigal Pharmaceuticals Announces Publication Of Health-Related Quality Of Life Results From The Phase 3 MAESTRO-NASH Trial Of Rezdiffra

madrigal pharmaceuticals宣佈從第3階段MAESTRO-NASH試驗的Rezdiffra中公佈了相關健康生活質量結果
Benzinga ·  09/30 20:03
  • Patients with MASH/NASH treated with Rezdiffra experienced clinically meaningful and statistically significant improvements in emotional well-being and health distress
  • Study results underscore the positive tolerability profile of Rezdiffra
  • 接受Rezdiffra治療的MASH/NASH患者在情緒幸福感和健康困擾方面經歷了臨床上意義重大且統計學上顯著的改善。
  • 研究結果突顯了Rezdiffra的積極耐受性特徵。

CONSHOHOCKEN, Pa., Sept. 30, 2024 (GLOBE NEWSWIRE) -- Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL), a biopharmaceutical company focused on delivering novel therapeutics for nonalcoholic steatohepatitis (NASH)/metabolic dysfunction-associated steatohepatitis (MASH), today announced the publication of positive patient-reported outcomes data demonstrating Rezdiffra (resmetirom) improved health-related quality of life (HRQL) in patients with NASH with moderate to advanced fibrosis. The results were published in the journal Hepatology.

賓夕法尼亞州康紹霍肯,2024年9月30日(環球新聞社)--Madrigal Pharmaceuticals, Inc.(納斯達克股票代碼:MDGL)一家專注於提供新型治療方案的生物製藥公司,專注於治療非酒精性脂肪肝(NASH)/代謝功能障礙性脂肪肝(MASH)的藥物,今日宣佈發表了積極的患者報告結論數據,顯示Rezdiffra(雷西替胺)改善了NASH伴有中度至愛文思控股纖維化的患者的與健康相關的生活質量(HRQL)。這些結果發表在《肝臟病學》雜誌上。

Rezdiffra is a once-daily, oral, liver-directed thyroid hormone receptor (THR)-β agonist designed to target key underlying causes of NASH. It is the first FDA-approved medication for the treatment of NASH. In the pivotal Phase 3 MAESTRO-NASH biopsy trial, Rezdiffra achieved both fibrosis improvement and NASH resolution primary endpoints, and 80% of patients treated with Rezdiffra 100 mg experienced improvement or stabilization of fibrosis. Rezdiffra is indicated in conjunction with diet and exercise for the treatment of adults with noncirrhotic NASH with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis). Continued approval for this indication may be contingent upon verification and description of clinical benefit in ongoing confirmatory trials.

Rezdiffra是一種每日一次口服的肝臟定向甲狀腺激素受體(THR)-β激動劑,旨在針對NASH的關鍵潛在原因。這是首個FDA批准用於治療NASH的藥物。在關鍵的第3期MAESTRO-NASH活檢試驗中,Rezdiffra實現了纖維化改善和NASH緩解的主要終點,而使用100毫克Rezdiffra治療的患者中,80%的患者經歷了纖維化改善或穩定化。Rezdiffra適用於與飲食和鍛鍊相結合,用於治療非肝硬化性NASH伴有中度至愛文思控股肝纖維化的成年人(符合F2到F3纖維化階段)。該適應症的持續批准可能取決於正在進行的確認性試驗中的臨床益處的驗證和描述。

譯文內容由第三人軟體翻譯。


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