Pfizer's Combo Therapy For Fatty Liver Disease Gets FDA Fast Track Status
Pfizer's Combo Therapy For Fatty Liver Disease Gets FDA Fast Track Status
The U.S. Food and Drug Administration has granted Fast Track designation to$辉瑞(PFE.US)$Ervogastat/Clesacostat Combination therapy for the treatment of Non-Alcoholic Steatohepatitis (NASH).
The Ervogastat/Clesacostat combination is being investigated in an ongoing Phase 2 clinical trial evaluating the impact of treatment on resolution of NASH or improvement in liver fibrosis.
The FDA's decision is supported by results of nonclinical studies and results of Phase 2a clinical study that showed that treatment with combination therapy reduced liver fat with a favorable safety and tolerability profile.
James Rusnak, M.D., Ph.D., Senior Vice President and Chief Development Officer, commented: "Receiving Fast Track designation from the FDA reinforces Pfizer's belief in ervogastat/clesacostat as a potential treatment for NASH, a serious, progressive liver disease with no currently approved therapies."
Fast Track Designation is intended to expedite the development and review of new drugs to treat serious medical conditions that fill unmet medical needs.
Price Check: Shares of Pfizer are trading higher at $53.95 in Thursday's premarket session, according to Benzinga Pro.
The U.S. Food and Drug Administration has granted Fast Track designation to$辉瑞(PFE.US)$Ervogastat/Clesacostat Combination therapy for the treatment of Non-Alcoholic Steatohepatitis (NASH).
美國食品和藥物管理局已授予快車道稱號$輝瑞(PFE.US)$Ervogastat/Clesaco stat聯合治療非酒精性脂肪性肝炎(NASH)
The Ervogastat/Clesacostat combination is being investigated in an ongoing Phase 2 clinical trial evaluating the impact of treatment on resolution of NASH or improvement in liver fibrosis.
Ervogastat/Clesaco stat的組合正在進行的第二階段臨牀試驗中正在進行研究，評估治療對NASH的緩解或改善肝纖維化的影響。
The FDA's decision is supported by results of nonclinical studies and results of Phase 2a clinical study that showed that treatment with combination therapy reduced liver fat with a favorable safety and tolerability profile.
FDA的決定得到了非臨牀研究結果和2a期臨牀研究結果的支持，這些結果表明，聯合治療降低了肝臟脂肪，具有良好的安全性和耐受性。
James Rusnak, M.D., Ph.D., Senior Vice President and Chief Development Officer, commented: "Receiving Fast Track designation from the FDA reinforces Pfizer's belief in ervogastat/clesacostat as a potential treatment for NASH, a serious, progressive liver disease with no currently approved therapies."
詹姆斯·魯斯納克，醫學博士，高級副總裁兼首席開發官評論説：“獲得FDA的快速通道稱號加強了輝瑞公司對ervogastat/clesaco stat作為治療NASH的潛在療法的信念。NASH是一種嚴重的進行性肝病，目前還沒有獲得批准的治療方法。”
Fast Track Designation is intended to expedite the development and review of new drugs to treat serious medical conditions that fill unmet medical needs.
快速通道指定旨在加快新藥的開發和審查，以治療滿足未得到滿足的醫療需求的嚴重疾病。
Price Check: Shares of Pfizer are trading higher at $53.95 in Thursday's premarket session, according to Benzinga Pro.
價格檢查：根據Benzinga Pro的數據，在週四的盤前交易中，輝瑞的股價上漲至53.95美元。
譯文內容由第三人軟體翻譯。
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