FDA Approves Gilead's Seladelpar For Inflammatory Liver Disease, Acquired Via $4B CymaBay Deal
FDA Approves Gilead's Seladelpar For Inflammatory Liver Disease, Acquired Via $4B CymaBay Deal
The accelerated approval was based primarily on pivotal placebo-controlled Phase 3 RESPONSE study data.On Wednesday, the FDA granted accelerated approval for Gilead Sciences, Inc.'s (NASDAQ:GILD) Livdelzi (seladelpar) for primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have had an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA.
FDA在周三授予吉利德科学公司（NASDAQ:GILD）的Livdelzi（seladelpar）加速批准，可用于与优舒酸（UDCA）联合治疗肝内胆管炎（PBC）的成年人，其中UDCA效果不佳，或在不能耐受UDCA患者中作为单药治疗。
The use of Livdelzi is not recommended for people who have or develop decompensated cirrhosis.
不建议在肝硬化未能纠正的患者中使用Livdelzi。
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The accelerated approval was based primarily on pivotal placebo-controlled Phase 3 RESPONSE study data.
加速批准主要基于关键的安慰剂对照第3期RESPONSE研究数据。
In the study, 62% of participants taking Livdelzi achieved the primary endpoint of composite biochemical response at month 12, versus 20% of participants taking placebo.
在研究中，62%的Livdelzi患者在第12个月达到复合生化反应的主要终点指标，而参加安慰剂组的患者只有20%。
Treatment with Livdelzi led to the normalization of alkaline phosphatase (ALP) values, a cholestatic marker that is a predictor of risk for liver transplant and death, in 25% of trial participants at month 12.
治疗Livdelzi后，25%的试验参与者在第12个月时碱性磷酸酶（ALP）值正常化，这是一种胆汁淤积标志物，是肝移植和死亡风险的预测因素。
This change was not seen in any trial participants receiving a placebo.
没有看到任何安慰剂组试验参与者发生这种变化。
Change from baseline pruritus (itch) score at month 6 was a key secondary endpoint; patients treated with Livdelzi demonstrated a statistically significant reduction in pruritus compared with placebo.
月份6基线瘙痒（痒）评分变化是一个重要的次要终点；与安慰剂组相比，使用Livdelzi治疗的患者的瘙痒得到了统计学显著的缓解。
The FDA approved Livdelzi under accelerated approval based on a reduction of ALP.
FDA根据ALP的降低批准Livdelzi加速批准。
Improvement in survival or prevention of liver decompensation events has not been demonstrated.
未证明生存率的改善或肝脏失功事件的预防。
Continued approval of Livdelzi for the approved indication may be contingent on verification and description of clinical benefit in the confirmatory trial(s).
Livdelzi在确认性试验中的临床益处得到验证和描述时，批准有关适应症的继续使用可能取决于此。
PBC is a rare, chronic, autoimmune disease of the bile ducts that affects approximately 130,000 Americans, primarily women, and can cause liver damage and possible liver failure if untreated.
PBC是涉及胆管的罕见慢性自身免疫性疾病，影响约13万名美国人，主要是女性，如果不治疗可能会导致肝损害和肝衰竭。
Gilead added seladelpar via the acquisition of CymaBay Therapeutics Inc. for $32.50 per share in cash or a total equity value of $4.3 billion.
吉利德以每股32.50美元的现金或总资产价值43亿美元的价格通过收购CymaBay Therapeutics Inc.加入了seladelpar。
Seladelpar has also been accepted for review by the UK Medicines and Healthcare products Regulatory Agency (MHRA) and the European Medicines Agency (EMA).
Seladelpar也已被英国药品和医疗保健产品监管局（MHRA）和欧洲药品管理局（EMA）接受审查。
Price Action: At last check Thursday, GILD stock was down 0.04% at $74.11 during the premarket session.
截至周四消息，盖奇尔(GILD)股票的盘前交易价为74.11美元，下跌了0.04%。
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Photo via Shutterstock
图片来自shutterstock。