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 (场外交易:IPSEF) (场外交易:IPSEY) 于周一宣布，美国食品和药物管理局（FDA）已加速批准 Iqirvo（elafibranor）80毫克片剂，用于治疗原发性胆汁性肝炎（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是一种罕见的自身免疫性胆汁淤积性肝病，胆汁和毒素的积聚和慢性炎症导致肝纤维化不可逆和胆管破坏。
This drug is approved for use with ursodeoxycholic acid (UDCA) or as a standalone treatment in cases where UDCA is not tolerated.
该药物已获批准与ursodeoxycholic acid (UDCA) 同用，或作为UDCA耐受情况下的单独治疗。
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是首个类别为口服每日一次的过氧化物酶体增殖物激活受体（PPAR）激动剂，由GENFIT S.A.（纳斯达克:GNFT）于2021年授权许可。
The expedited approval is based on the medication's ability to reduce levels of alkaline phosphatase (ALP), an indicator of liver health.
该药物被加速批准的基础是该药物能够减少碱性磷酸酶（ALP）水平，该指标是肝健康的一个指标。
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.
持续的批准将取决于进一步的确认试验。Iqirvo的批准是基于第三阶段ELATIVE试验的有希望结果，该试验已发表在《新英格兰医学杂志》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.
对于该药物的研究发现，接受Iqirvo治疗的患者，同时使用UDCA，与接受安慰剂治疗的患者相比，其首要生化反应的成功率提高了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开发并由Ipsen商业化的Iqirvo现在可以在美国处方，为治疗PBC提供了一种新的治疗选择。
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预计在2024年从伊普森（Ipsen）获得约8900万欧元的重大里程碑款项，其中包括预计从Iqirvo在美国的初步销售中获得4870万欧元。
PBC impacts approximately 100,000 people in the U.S. and is growing globally. If inadequately treated, it can cause liver failure.
PBC在美国影响约10万人，并且在全球范围内正在增长。如果治疗不当，可能导致肝功能衰竭。
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研发执行副总裁Christelle Huguet表示:"与UDCA单独相比，Iqirvo在生化反应方面的改善是具有统计学意义的。因此，Iqirvo是一种迫切需要的治疗选择，是近十年来治疗PBC的第一种新药物。"
Iqirvo is priced at approximately $11,500 for a monthly supply, Reuters reported.
据路透社报道，一个月的Iqirvo的价格约为11,500美元。
Price Action: GNFT shares are trading lower by 1.45% at $5.50 in premarket at the last check Tuesday.
据最近的周二最后一次检查显示，GNFT股票在盘前交易中下跌1.45％，为5.50美元。
Disclaimer: This content was partially produced with the help of AI tools and was reviewed and published by Benzinga editors.
免责声明: 此内容部分使用人工智能工具生成，并由Benzinga编辑审查和发布。
Photo via Shutterstock
图片来自shutterstock。
