FDA Fast-Tracks Ipsen And Genfit's New Liver Disease Treatment, Iqirvo
FDA Fast-Tracks Ipsen And Genfit's New Liver Disease Treatment, Iqirvo
Iqirvo is a first-in-class oral, once-daily peroxisome proliferator-activated receptor (PPAR) agonist. Iqirvo was in-licensed from GENFIT S.A. (NASDAQ:GNFT) in 2021.Ipsen SA (OTC:IPSEF) (OTC:IPSEY) announced Monday that the U.S. Food and Drug Administration (FDA) had granted accelerated approval for Iqirvo (elafibranor) 80 mg tablets to treat primary biliary cholangitis (PBC).
Ipsen SA (場外交易:IPSEF) (場外交易:IPSEY) 於週一宣佈，美國食品和藥物管理局（FDA）已加速批准 Iqirvo（elafibranor）80毫克片劑，用於治療原發性膽汁性肝炎（PBC） 。
PBC is a rare, autoimmune, cholestatic liver disease where a build-up of bile and toxins and chronic inflammation causes irreversible fibrosis of the liver and destruction of the bile ducts.
PBC是一種罕見的自身免疫性膽汁淤積性肝病，膽汁和毒素的積聚和慢性炎症導致肝纖維化不可逆和膽管破壞。
This drug is approved for use with ursodeoxycholic acid (UDCA) or as a standalone treatment in cases where UDCA is not tolerated.
該藥物已獲批准與ursodeoxycholic acid (UDCA) 同用，或作爲UDCA耐受情況下的單獨治療。
Iqirvo is a first-in-class oral, once-daily peroxisome proliferator-activated receptor (PPAR) agonist. Iqirvo was in-licensed from GENFIT S.A. (NASDAQ:GNFT) in 2021.
Iqirvo是首個類別爲口服每日一次的過氧化物酶體增殖物激活受體（PPAR）激動劑，由GENFIT S.A.（納斯達克:GNFT）於2021年授權許可。
The expedited approval is based on the medication's ability to reduce levels of alkaline phosphatase (ALP), an indicator of liver health.
該藥物被加速批准的基礎是該藥物能夠減少鹼性磷酸酶（ALP）水平，該指標是肝健康的一個指標。
Continued approval will depend on further verification in confirmatory trials. The approval of Iqirvo follows promising results from the Phase III ELATIVE trial, which was published in the New England Journal of Medicine.
持續的批准將取決於進一步的確認試驗。Iqirvo的批准是基於第三階段ELATIVE試驗的有希望結果，該試驗已發表在《新英格蘭醫學雜誌》上。
The study found that patients treated with Iqirvo, in addition to UDCA, were 13 times more likely to achieve a primary biochemical response compared to those receiving a placebo.
對於該藥物的研究發現，接受Iqirvo治療的患者，同時使用UDCA，與接受安慰劑治療的患者相比，其首要生化反應的成功率提高了13倍。
Iqirvo, developed by Genfit and commercialized by Ipsen, is now available for prescription in the U.S., offering a new therapeutic option for treating PBC.
由Genfit開發並由Ipsen商業化的Iqirvo現在可以在美國處方，爲治療PBC提供了一種新的治療選擇。
In 2024, GENFIT anticipates substantial milestone payments from Ipsen totaling approximately €89 million, which include €48.7 million expected from the initial U.S. sales of Iqirvo.
GENFIT預計在2024年從伊普森（Ipsen）獲得約8900萬歐元的重大里程碑款項，其中包括預計從Iqirvo在美國的初步銷售中獲得4870萬歐元。
PBC impacts approximately 100,000 people in the U.S. and is growing globally. If inadequately treated, it can cause liver failure.
PBC在美國影響約10萬人，並且在全球範圍內正在增長。如果治療不當，可能導致肝功能衰竭。
Christelle Huguet, Executive Vice President, Head of Research and Development at Ipsen, said, "Iqirvo demonstrated statistically significant improvements in biochemical response compared to UDCA alone. Iqirvo is therefore a much-needed treatment option and the first new medicine for PBC in nearly a decade."
Ipsen研發執行副總裁Christelle Huguet表示:"與UDCA單獨相比，Iqirvo在生化反應方面的改善是具有統計學意義的。因此，Iqirvo是一種迫切需要的治療選擇，是近十年來治療PBC的第一種新藥物。"
Iqirvo is priced at approximately $11,500 for a monthly supply, Reuters reported.
據路透社報道，一個月的Iqirvo的價格約爲11,500美元。
Price Action: GNFT shares are trading lower by 1.45% at $5.50 in premarket at the last check Tuesday.
據最近的週二最後一次檢查顯示，GNFT股票在盤前交易中下跌1.45％，爲5.50美元。
Disclaimer: This content was partially produced with the help of AI tools and was reviewed and published by Benzinga editors.
免責聲明: 此內容部分使用人工智能工具生成，並由Benzinga編輯審查和發佈。
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譯文內容由第三人軟體翻譯。
