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)$Ervogastat/Clesacostat Combination therapy for the treatment of Non-Alcoholic Steatohepatitis (NASH).
美国食品和药物管理局已授予快车道称号$辉瑞(PFE.US)$Ervogastat/Clesaco stat联合治疗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的组合正在进行的第二阶段临床试验中正在进行研究，评估治疗对NASH的缓解或改善肝纤维化的影响。
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的决定得到了非临床研究结果和2a期临床研究结果的支持，这些结果表明，联合治疗降低了肝脏脂肪，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·鲁斯纳克，医学博士，高级副总裁兼首席开发官评论说：“获得FDA的快速通道称号加强了辉瑞公司对ervogastat/clesaco stat作为治疗NASH的潜在疗法的信念。NASH是一种严重的进行性肝病，目前还没有获得批准的治疗方法。”
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药的开发和审查，以治疗满足未得到满足的医疗需求的严重疾病。
Price Check: Shares of Pfizer are trading higher at $53.95 in Thursday's premarket session, according to Benzinga Pro.
价格检查：根据Benzinga Pro的数据，在周四的盘前交易中，辉瑞的股价上涨至53.95美元。
译文内容由第三方软件翻译。
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