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在週三授予吉利德科學公司（NASDAQ:GILD）的Livdelzi（seladelpar）加速批准，可用於與優舒酸（UDCA）聯合治療肝內膽管炎（PBC）的成年人，其中UDCA效果不佳，或在不能耐受UDCA患者中作爲單藥治療。
The use of Livdelzi is not recommended for people who have or develop decompensated cirrhosis.
不建議在肝硬化未能糾正的患者中使用Livdelzi。
Also Read: Analysts Cite Improved Investor Sentiment For Gilead, But Warn of Limited Growth at Current Stock Levels.
此外還可閱讀：分析師們引用Gilead的投資者情緒改善，但警告稱當前股票水平增長有限。
The accelerated approval was based primarily on pivotal placebo-controlled Phase 3 RESPONSE study data.
加速批准主要基於關鍵的安慰劑對照第3期RESPONSE研究數據。
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個月達到複合生化反應的主要終點指標，而參加安慰劑組的患者只有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.
治療Livdelzi後，25%的試驗參與者在第12個月時鹼性磷酸酶（ALP）值正常化，這是一種膽汁淤積標誌物，是肝移植和死亡風險的預測因素。
This change was not seen in any trial participants receiving a placebo.
沒有看到任何安慰劑組試驗參與者發生這種變化。
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基線瘙癢（癢）評分變化是一個重要的次要終點；與安慰劑組相比，使用Livdelzi治療的患者的瘙癢得到了統計學顯著的緩解。
The FDA approved Livdelzi under accelerated approval based on a reduction of ALP.
FDA根據ALP的降低批准Livdelzi加速批准。
Improvement in survival or prevention of liver decompensation events has not been demonstrated.
未證明生存率的改善或肝臟失功事件的預防。
Continued approval of Livdelzi for the approved indication may be contingent on verification and description of clinical benefit in the confirmatory trial(s).
Livdelzi在確認性試驗中的臨床益處得到驗證和描述時，批准有關適應症的繼續使用可能取決於此。
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是涉及膽管的罕見慢性自身免疫性疾病，影響約13萬名美國人，主要是女性，如果不治療可能會導致肝損害和肝衰竭。
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美元的現金或總資產價值43億美元的價格通過收購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也已被英國藥品和醫療保健產品監管局（MHRA）和歐洲藥品管理局（EMA）接受審查。
Price Action: At last check Thursday, GILD stock was down 0.04% at $74.11 during the premarket session.
截至週四消息，蓋奇爾(GILD)股票的盤前交易價爲74.11美元，下跌了0.04%。
- Gilead's $42.5K Priced HIV Drug Could Be Made At Just $40 Annually, Campaigners Urge Company To Slash Price.
- 吉利德的定價在42500美元的HIV藥物每年只需40美元，遊說者敦促其大幅削減價格。
Photo via Shutterstock
圖片來自shutterstock。