Ipsen presents 3 late-breaking presentations and 8 abstracts across rare cholestatic liver disease portfolio at AASLD 2024

Ipsen在AASLD 2024年的罕见胆汁淤积性肝病组合中发表了3篇最新的演讲和8篇摘要

Iqirvo approved for use in the U.S. in June 2024, in the E.U. in September 2024 and in the U.K. in October 2024

Iqirvo于2024年6月批准在美国、2024年9月在欧盟和2024年10月在英国使用

PARIS, FRANCE, 15 November 2024 Ipsen (Euronext: IPN; ADR: IPSEY) announced today late-breaking data for Iqirvo® (elafibranor 80 mg tablets) from an interim analysis of the ongoing open-label extension of the Phase III ELATIVE® study at the American Association for the Study of Liver Disease (AASLD) congress.

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The late-breaking presentations (Abstract #5041 and Abstract #5042) report on biomarkers of cholestasis, stabilization of surrogate markers of liver fibrosis and moderate-to-severe pruritus data for up to three years in Iqirvo-treated patients. Additionally, exploratory endpoints in fatigue and sleep were evaluated using patient-reported outcomes tools..

迟发性报告（摘要#5041和摘要#5042）报告了Iqirvo治疗患者胆汁淤积的生物标志物，肝纤维化替代标志物的稳定以及长达三年的中度至重度瘙痒数据。此外，使用患者报告的结果工具评估了疲劳和睡眠的探索性终点。。

“Over three years, Iqirvo data suggest sustained efficacy and support the safety profile of the medicine. Importantly, when patients tell me they are less impacted by itch and fatigue—that matters to me as a physician,” said Dr. Kris Kowdley, Director at The Liver Institute Northwest, Washington and a primary investigator on the ELATIVE study.

华盛顿西北肝脏研究所主任、ELATIVE研究的主要研究者克里斯·科德利博士说：“三年来，Iqirvo的数据表明该药具有持续的疗效，并支持其安全性。重要的是，当患者告诉我，他们受瘙痒和疲劳的影响较小，这对我作为医生来说很重要。”。

“Treatment with Iqirvo had an impact on symptoms of pruritus and surrogate markers of fibrosis, which are important findings for people living with PBC.”.

“Iqirvo治疗对瘙痒症状和纤维化替代指标有影响，这是PBC患者的重要发现。”。

“Fatigue is a symptom often reported by people living with PBC and is also very challenging to manage,” said Dr. Mark Swain, Department of Medicine, Cumming School of Medicine, University of Calgary, Canada. “Patients treated with Iqirvo reported improvement in fatigue and sleep, across several patient-reported outcome measures.”.

加拿大卡尔加里大学卡明医学院医学系Mark Swain博士说：“疲劳是PBC患者经常报告的症状，管理起来也非常困难。”。“在几项患者报告的结果测量中，接受Iqirvo治疗的患者报告了疲劳和睡眠的改善。”。

The open-label extension (OLE) included 138 patients who completed the double-blind period of the Phase III ELATIVE® study1. This interim analysis was performed after at least one year of treatment with Iqirvo in the OLE (up to three years total). In patients receiving three years of continuous treatment with Iqirvo across the double-blind period and OLE (n=13), 85 percent had a biochemical response (n=11/13; ALP <1.67 x ULN, with ≥ 15% reduction from baseline and total bilirubin ≤ ULN) and 39 percent achieved ALP normalization (n=5/13) at week 156.

。这项中期分析是在OLE中使用Iqirvo治疗至少一年后进行的（总共三年）。在双盲期和OLE（n=13）接受Iqirvo连续治疗三年的患者中，85%有生化反应（n=11/13；ALP<1.67 x ULN，比基线降低≥15%，总胆红素≤ULN），39%在第156周达到ALP正常化（n=5/13）。

Surrogate markers of liver fibrosis, liver stiffness measurements (n=23) and enhanced liver fibrosis (ELF™) (n=19) scores, suggest stabilization when measured from baseline to week 130. In patients continuously receiving Iqirvo for up to 156 weeks, pruritus improvements were sustained for patients with moderate or severe pruritus at baseline (n=5).

肝纤维化的替代标志物，肝硬度测量（n=23）和增强的肝纤维化（ELF™）（n=19）评分表明，从基线到第130周测量时稳定。在连续接受Iqirvo长达156周的患者中，基线时中度或重度瘙痒症患者的瘙痒症持续改善（n=5）。

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No new safety findings were observed. The most common treatment-emergent adverse events (>10 percent) occurring more frequently in patients treated with Iqirvo than placebo in the double-blind period of the trial (abdominal pain, diarrhea, nausea and vomiting) were also reported in the OLE.

没有观察到新的安全性发现。OLE中还报告了在试验的双盲期（腹痛，腹泻，恶心和呕吐）中，Iqirvo治疗的患者比安慰剂治疗的患者发生最常见的治疗紧急不良事件（>10%）。

The impact of Iqirvo on fatigue and sleep were investigated as an exploratory endpoint in the OLE.2 Changes in fatigue or sleepiness (including normal sleep) were reviewed from baseline to week 104 looking at the minimal clinically important differences and categorical changes (n=48). Fatigue and sleep improvements for patients treated with Iqirvo were observed at week 104 across three patient-reported outcome (PRO) tools.

Iqirvo对疲劳和睡眠的影响作为OLE的探索性终点进行了研究。2从基线到第104周，对疲劳或嗜睡（包括正常睡眠）的变化进行了回顾，观察了最小的临床重要差异和分类变化（n=48）。在第104周，通过三种患者报告的结果（PRO）工具观察到接受Iqirvo治疗的患者的疲劳和睡眠改善。

In patients with moderate-to-severe fatigue or excessive sleepiness at baseline, clinically meaningful improvements were observed after 104 weeks of treatment with Iqirvo in 56 percent (n=18) of patients according to the PRO Measurement Information System (PROMIS) Fatigue Short Form 7a, 50 percent (n=24) of patients according to the fatigue domain of the PBC-40, and 69 percent (n=16) of patients according to the Epworth Sleepiness Scale (ESS).

在基线时中度至重度疲劳或过度嗜睡的患者中，根据PRO测量信息系统（PROMIS）疲劳简表7a，56%（n=18）的患者接受Iqirvo治疗104周后观察到临床上有意义的改善，根据PBC-40的疲劳域，50%（n=24）的患者和根据Epworth嗜睡量表（ESS）的69%（n=16）的患者。

These are interim data and have not been submitted to regulatory agencies. A confirmatory study of Iqirvo is ongoing (NCT06016842)..

这些是临时数据，尚未提交给监管机构。Iqirvo的验证性研究正在进行中（NCT06016842）。。

“People living with PBC tell us just how devastating this disease can be for patients and their families,” said Sandra Silvestri, EVP and Chief Medical Officer, Ipsen. “Data like these continue to provide prescribers with a clear rationale for Iqirvo. As the first-in-class PPAR approved for the treatment of PBC, Iqirvo is on track to be the treatment of choice for patients living with PBC.

Ipsen执行副总裁兼首席医疗官桑德拉·西尔维斯特里（SandraSilvestri）说：“患有PBC的人告诉我们，这种疾病对患者及其家人的破坏性有多大。”。“类似的数据继续为处方者提供Iqirvo的明确理由。作为批准用于治疗PBC的第一类PPAR，Iqirvo有望成为PBC患者的首选治疗方法。

Ipsen is committed to being a leader the rare liver community can count on.”.

Ipsen致力于成为稀有肝脏社区可以信赖的领导者。”。

About PBCPBC is a rare, autoimmune, cholestatic liver disease where a build-up of bile and toxins (cholestasis) and chronic inflammation causes irreversible fibrosis (scarring) of the liver and destruction of the bile ducts. Impacting approximately 100,000 people in the U.S.,3 the majority being women, PBC is a lifelong condition that can worsen over time if not effectively treated, may lead to liver transplant and in some cases, premature death.

关于PBCPBC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（胆汁淤积）和慢性炎症会导致肝脏不可逆的纤维化（瘢痕形成）和胆管破坏。PBC在美国约有10万人受到影响，其中大多数是女性，PBC是一种终身疾病，如果不有效治疗，可能会随着时间的推移而恶化，可能导致肝移植，在某些情况下还会导致过早死亡。

The high symptom burden of PBC can also have an impact on daily life..

PBC的高症状负担也会对日常生活产生影响。。

Iqirvo (elafibranor) posters presented at AASLD

在AASLD上展示的Ikirvo（elafibranor）海报

Poster or Oral #

海报或口头#

Full Title

完整标题

Authors

作者

Poster, Abstract [5041]​Monday 18 November​13:00–14:00​Poster Session IV​

海报，摘要[5041]11月18日星期一13:00–14:00海报第四次会议

Long-term efficacy and safety of elafibranor in primary biliary cholangitis: Interim results from the open-label extension of the ELATIVE® trial up to 3 years ​

elafibranor治疗原发性胆汁性胆管炎的长期疗效和安全性：ELATIVE®试验开放标签延长至3年的中期结果

Kris V. Kowdley et al.​

Kris V.Kowdley等人。

Poster, Abstract [5042]​Monday 18 November​13:00–14:00​Poster Session IV​

海报，摘要[5042]11月18日星期一13:00–14:00海报第四课

Impact of elafibranor on fatigue in patients with primary biliary cholangitis: Interim results from the long-term open-label extension of the ELATIVE® trial ​

elafibranor对原发性胆汁性胆管炎患者疲劳的影响：ELATIVE®试验长期开放标签延长的中期结果

Mark Swain et al. ​

Mark Swain等人。

Poster, Abstract [4274]​Monday 18 November​13:00–14:00​Poster Session IV​

海报，摘要[4274]11月18日星期一13:00–14:00海报第四课

Beyond the mean: Exploring the impact of baseline alkaline phosphatase levels on endpoints in primary biliary cholangitis​

超越平均值：探索基线碱性磷酸酶水平对原发性胆汁性胆管炎终点的影响

Cynthia Levy et al.​

Cynthia Levy等人

Oral, Abstract Parallel, ePoster [43]​Monday 18 November​11:00–11:15 ​Human Cholestatic, PBC and other Biliary Disorders in Children and Adults​

11月18日星期一11:00-11:15儿童和成人的胆汁淤积症、PBC和其他胆道疾病

One-year treatment with elafibranor in the Phase III ELATIVE® trial improves GLOBE and UK-PBC prognostic scores​

elafibranor在III期ELATIVE®试验中的一年治疗可改善GLOBE和UK-PBC预后评分

Kris V. Kowdley et al. ​

Kris V.Kowdley等人。

Poster, Abstract [4292]​Monday 18 November​13:00–14:00​Poster Session IV​

海报，摘要[4292]11月18日星期一13:00–14:00海报第四课

Use of machine learning (ML) models to stratify response patterns to first-line treatment of primary biliary cholangitis (PBC) with ursodeoxycholic acid (UDCA)​

使用机器学习（ML）模型对熊去氧胆酸（UDCA）一线治疗原发性胆汁性胆管炎（PBC）的反应模式进行分层

Seema T. Meloni et al. ​

Seema T.Meloni等人。

Poster, Abstract [4349]​Monday 18 November​13:00–14:00​Poster Session IV​

海报，摘要[4349]11月18日星期一13:00–14:00海报第四次会议

Elafibranor has no impact on markers of renal function in primary biliary cholangitis: results from the Phase III ELATIVE® trial​

Elafibranor对原发性胆汁性胆管炎的肾功能标志物没有影响：III期ELATIVE®试验的结果

Marcelo Kugelmas et al.​

Marcelo Kugelmas等人

Poster, Abstract [4358]​Monday 18 November​13:00–14:00​Poster Session IV​

海报，摘要[4358]11月18日星期一13:00–14:00海报第四课

Economic burden of patients with primary biliary cholangitis and experiencing fatigue or pruritus in the United States​

美国原发性胆汁性胆管炎和疲劳或瘙痒患者的经济负担

Nisreen Shamseddine et al.

Nisreen Shamseddine等人。

About Iqirvo® (elafibranor) 80 mg tabletIqirvo is an oral, once-daily, peroxisome proliferator-activated receptor (PPAR), indicated for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA.

关于Iqirvo®（elafibranor）80 mg tabletIqirvo是一种口服，每日一次的过氧化物酶体增殖物激活受体（PPAR），用于治疗对UDCA反应不足的成人原发性胆汁性胆管炎（PBC）联合熊去氧胆酸（UDCA），或作为无法耐受UDCA的患者的单一疗法。

While the mechanism is not well understood, pharmacological activity that is potentially relevant to Iqirvo therapeutic effects includes inhibition of bile acid synthesis through activation of PPAR-alpha and PPAR-delta. In 2019, Iqirvo was granted Breakthrough Therapy Designation by the U.S Food and Drug Administration (FDA) in adults with PBC who have an inadequate response to ursodeoxycholic acid (UDCA) the existing first-line therapy for PBC.

虽然机制尚不清楚，但与Iqirvo治疗效果潜在相关的药理活性包括通过激活PPAR-α和PPAR-δ来抑制胆汁酸合成。。

Iqirvo was granted U.S. FDA accelerated approval in June 2024, EU conditional approval by the EMA in September 2024 and UK Medicines and Healthcare products Regulatory Agency (MHRA) approval in October 2024, for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA.

2024年6月，Iqirvo获得美国FDA加速批准，2024年9月获得欧洲药品管理局（EMA）的欧盟有条件批准，2024年10月获得英国药品和保健品管理局（MHRA）的批准，用于治疗对UDCA反应不足的成年人的原发性胆汁性胆管炎（PBC）联合熊去氧胆酸（UDCA），或作为无法耐受UDCA的患者的单一疗法。

The FDA and EMA approvals are contingent on the further verification of clinical benefit. Iqirvo is currently in regulatory processes with other authorities. Iqirvo (elafibranor) was developed by GENFIT. Ipsen licensed the exclusive worldwide rights (except China, Hong Kong, Taiwan and Macau) to elafibranor from GENFIT in 2021..

FDA和EMA的批准取决于对临床益处的进一步验证。Iqirvo目前正在与其他当局进行监管。Iqirvo（elafibranor）由GENFIT开发。Ipsen于2021年从GENFIT向elafibranor授予了全球独家权利（中国、香港、台湾和澳门除外）。。

INDICATIONIQIRVO® is indicated for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA, or as monotherapy in adults unable to tolerate UDCA.

适应症IRVO®适用于对UDCA反应不足的成年人联合熊去氧胆酸（UDCA）治疗原发性胆汁性胆管炎（PBC），或用于无法耐受UDCA的成年人的单一疗法。

This indication is approved under accelerated approval based on reduction of alkaline phosphatase (ALP). Improvement in survival or prevention of liver decompensation events have not been demonstrated. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s)..

。尚未证明存活率的改善或肝失代偿事件的预防。是否继续批准该适应症可能取决于验证性试验中临床益处的验证和描述。。

Limitations of UseUse of IQIRVO is not recommended in patients who have or develop decompensated cirrhosis (e.g., ascites, variceal bleeding, hepatic encephalopathy).

使用限制对于患有或发展为失代偿性肝硬化（例如腹水，静脉曲张出血，肝性脑病）的患者，不建议使用IQIRVO。

IMPORTANT SAFETY INFORMATIONMyalgia, Myopathy, and Rhabdomyolysis: Rhabdomyolysis resulting in acute kidney injury occurred in one IQIRVO-treated patient who had cirrhosis at baseline and was also taking a stable dose of an HMG-CoA reductase inhibitor (statin). Myalgia or myopathy, with or without CPK elevations, occurred in patients treated with IQIRVO alone or treated concomitantly with a stable dose of an HMG-CoA reductase inhibitor.

重要安全信息肌痛，肌病和横纹肌溶解症：一名接受IQIRVO治疗的患者发生横纹肌溶解症，导致急性肾损伤，该患者在基线时患有肝硬化，并且正在服用稳定剂量的HMG-CoA还原酶抑制剂（他汀类药物）。单独使用IQIRVO或与稳定剂量的HMG-CoA还原酶抑制剂同时治疗的患者发生肌痛或肌病，有或没有CPK升高。

Assess for myalgia and myopathy prior to IQIRVO initiation. Consider periodic assessment (clinical exam, CPK measurement) during treatment with IQIRVO, especially in those who have signs and symptoms of new onset or worsening of muscle pain or myopathy. Interrupt IQIRVO treatment if there is new onset or worsening of muscle pain, or myopathy, or rhabdomyolysis..

在IQIRVO开始之前评估肌痛和肌病。在使用IQIRVO治疗期间，请考虑定期评估（临床检查，CPK测量），尤其是那些有新发或肌肉疼痛或肌病恶化迹象和症状的患者。如果肌肉疼痛、肌病或横纹肌溶解症新发或恶化，则中断IQIRVO治疗。。

Fractures: Fractures occurred in 6% of IQIRVO-treated patients compared to no placebo-treated patients. Consider the risk of fracture in the care of patients treated with IQIRVO and monitor bone health according to current standards of care.

骨折：与未接受安慰剂治疗的患者相比，接受IQIRVO治疗的患者中有6%发生骨折。考虑IQIRVO治疗患者的骨折风险，并根据当前的护理标准监测骨骼健康。

Adverse Effects on Fetal and Newborn Development: IQIRVO may cause fetal harm when administered during pregnancy. For females of reproductive potential, verify that the patient is not pregnant prior to initiation of therapy. Advise females of reproductive potential to use effective non-hormonal contraceptives or add a barrier method when using systemic hormonal contraceptives during treatment with IQIRVO and for 3 weeks following the last dose of IQIRVO..

对胎儿和新生儿发育的不利影响：IQIRVO在怀孕期间给药可能会导致胎儿伤害。对于具有生殖潜力的女性，在开始治疗之前，确认患者没有怀孕。建议有生殖潜力的女性在使用IQIRVO治疗期间和最后一剂IQIRVO后3周内使用有效的非激素避孕药或添加屏障方法。。

Drug-Induced Liver Injury: Drug-induced liver injury occurred in one patient who took IQIRVO 80 mg once daily and two patients who took IQIRVO at 1.5-times the recommended dosage, of which one presented with autoimmune-like hepatitis. The median time to onset of elevation in liver tests was 85 days.

药物性肝损伤：一名患者每天服用一次IQIRVO 80 mg，两名患者服用推荐剂量1.5倍的IQIRVO，其中一名患者出现自身免疫性肝炎。肝脏检查中出现升高的中位时间为85天。

Obtain baseline clinical and laboratory assessments at treatment initiation with IQIRVO and monitor thereafter according to routine patient management. Interrupt IQIRVO treatment if liver tests (ALT, AST, total bilirubin [TB], and/or alkaline phosphatase [ALP]) worsen, or the patient develops signs and symptoms consistent with clinical hepatitis (e.g., jaundice, right upper quadrant pain, eosinophilia).

在IQIRVO治疗开始时获得基线临床和实验室评估，然后根据常规患者管理进行监测。如果肝脏检查（ALT，AST，总胆红素[TB]和/或碱性磷酸酶[ALP]）恶化，或者患者出现与临床肝炎一致的体征和症状（例如黄疸，右上腹疼痛，嗜酸性粒细胞增多），则中断IQIRVO治疗。

Consider permanent discontinuation if liver tests worsen after restarting IQIRVO..

如果重新启动IQIRVO后肝脏检查恶化，请考虑永久停药。。

Hypersensitivity Reactions: Hypersensitivity reactions have occurred in a clinical trial with IQIRVO at 1.5-times the recommended dosage. Three patients (0.2%) had rash or unspecified allergic reaction that occurred 2 to 30 days after IQIRVO initiation. Hypersensitivity reactions resolved after discontinuation of IQIRVO and treatment with steroids and/or antihistamines.

超敏反应：IQIRVO的临床试验中发生了超敏反应，剂量是推荐剂量的1.5倍。三名患者（0.2%）在IQIRVO开始后2至30天出现皮疹或未指定的过敏反应。停用IQIRVO并用类固醇和/或抗组胺药治疗后，超敏反应得到解决。

If a severe hypersensitivity reaction occurs, permanently discontinue IQIRVO. If a mild or moderate hypersensitivity reaction occurs, interrupt IQIRVO and treat promptly. Monitor the patient until signs and symptoms resolve. If a hypersensitivity reaction recurs after IQIRVO rechallenge, then permanently discontinue IQIRVO..

如果发生严重的超敏反应，请永久停止IQIRVO。如果发生轻度或中度超敏反应，请中断IQIRVO并立即治疗。监测患者直到体征和症状消失。。。

Biliary Obstruction: Avoid use of IQIRVO in patients with complete biliary obstruction. If biliary obstruction is suspected, interrupt IQIRVO and treat as clinically indicated.

胆道梗阻：完全性胆道梗阻患者应避免使用IQIRVO。如果怀疑胆道梗阻，中断IQIRVO并根据临床指示进行治疗。

Drug-Drug Interactions

药物相互作用

IQIRVO may reduce the systemic exposure of progestin and ethinyl estradiol (CYP3A4 substrates), which may lead to contraceptive failure and/or an increase in breakthrough bleeding. Switch to effective non-hormonal contraceptives or add a barrier method when using hormonal contraceptives during treatment with IQIRVO and for at least 3 weeks after last dose..

IQIRVO可以减少孕激素和炔雌二醇（CYP3A4底物）的全身暴露，这可能导致避孕失败和/或突破性出血增加。在IQIRVO治疗期间以及最后一次服用后至少3周内使用激素避孕药时，请改用有效的非激素避孕药或添加屏障方法。。

CPK elevation and/or myalgia occurred in patients on IQIRVO monotherapy. Co-administration of IQIRVO and HMG-CoA reductase inhibitors can increase the risk of myopathy. Monitor for signs and symptoms of muscle injury. Consider periodic assessment (clinical exam, CPK) during treatment. Interrupt IQIRVO treatment if there is new onset or worsening of muscle pain or myopathy..

IQIRVO单药治疗患者发生CPK升高和/或肌痛。IQIRVO和HMG-CoA还原酶抑制剂的共同给药会增加肌病的风险。监测肌肉损伤的体征和症状。在治疗期间考虑定期评估（临床检查，CPK）。如果肌肉疼痛或肌病新发或恶化，请中断IQIRVO治疗。。

Co-administration of IQIRVO with rifampin, an inducer of metabolizing enzymes, may reduce the systemic exposure of elafibranor resulting in delayed or suboptimal biochemical response. Monitor the biochemical response (e.g., ALP and bilirubin) when patients initiate rifampin during treatment with IQIRVO..

IQIRVO与利福平（一种代谢酶的诱导剂）的共同给药可能会减少elafibranor的全身暴露，从而导致生化反应延迟或不理想。当患者在IQIRVO治疗期间开始服用利福平时，监测生化反应（例如ALP和胆红素）。。

Bile acid sequestrants may interfere with IQIRVO absorption and systemic exposure, which may reduce efficacy. Administer IQIRVO at least 4 hours before or after a bile acid sequestrant, or at as great an interval as possible.

胆汁酸螯合剂可能会干扰IQIRVO吸收和全身暴露，这可能会降低疗效。在胆汁酸隔离剂之前或之后至少4小时或以尽可能大的间隔给予IQIRVO。

Use in Special Populations

用于特殊人群

Pregnancy: Based on data from animal reproduction studies, IQIRVO may cause fetal harm when administered during pregnancy. There are insufficient data from human pregnancies exposed to IQIRVO to allow an assessment of a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes.

怀孕：根据动物繁殖研究的数据，IQIRVO在怀孕期间给药可能会导致胎儿伤害。暴露于IQIRVO的人类怀孕数据不足，无法评估与药物相关的重大出生缺陷，流产或其他不良孕产妇或胎儿结局的风险。

Report pregnancies to Ipsen Biopharmaceuticals, Inc. adverse event reporting line at 1-855-463-5127 or https://www.ipsen.com/contact-us/.Lactation: There are no data available on the presence of IQIRVO or its metabolites in human milk, or on effects of the drug on the breastfed infant or the effects on milk production.

向Ipsen Biopharmaceuticals，Inc.报告怀孕情况。不良事件报告热线：1-855-463-5127或https://www.ipsen.com/contact-us/.Lactation:没有关于母乳中IQIRVO或其代谢物存在的数据，也没有关于该药物对母乳喂养婴儿的影响或对产奶量的影响的数据。

IQIRVO is not recommended during breastfeeding and for at least 3 weeks following last dose of IQIRVO because the risk to breastfed child cannot be excluded..

不建议在母乳喂养期间以及最后一剂IQIRVO后至少3周内使用IQIRVO，因为不能排除母乳喂养儿童的风险。。

Females and Males of Reproductive Potential: IQIRVO may cause fetal harm when administered to pregnant women. Verify the pregnancy status of females of reproductive potential prior to initiating IQIRVO. Advise females of reproductive potential to use effective contraception during treatment with IQIRVO and for 3 weeks after the final dose..

生殖潜力的女性和男性：IQIRVO给孕妇服用时可能会造成胎儿伤害。在开始IQIRVO之前，验证具有生殖潜力的女性的妊娠状况。建议具有生殖潜力的女性在使用IQIRVO治疗期间和最终剂量后3周内使用有效的避孕措施。。

The most common adverse events occurring in ≥10% of patients were weight gain (23%), abdominal pain (11%), nausea (11%), vomiting (11%), and diarrhea (11%).

≥10%的患者最常见的不良事件是体重增加（23%），腹痛（11%），恶心（11%），呕吐（11%）和腹泻（11%）。

You are encouraged to report side effects to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Ipsen Biopharmaceuticals, Inc. at 1-855-463-5127.

我们鼓励您通过1-800-FDA-1088或www.FDA.gov/medwatch向FDA报告副作用。您也可以通过1-855-463-5127向Ipsen Biopharmaceuticals，Inc.报告副作用。

Please see full Prescribing Information for IQIRVO in the U.S.Please see full Prescribing Information for IQIRVO in the E.U.

请参阅美国IQIRVO的完整处方信息。请参阅欧盟IQIRVO的完整处方信息。

ENDS

结束

About Ipsen We are a global biopharmaceutical company with a focus on bringing transformative medicines to patients in three therapeutic areas: Oncology, Rare Disease and Neuroscience.

关于Ipsen，我们是一家全球生物制药公司，专注于在三个治疗领域为患者带来变革性药物：肿瘤学，罕见病和神经科学。

Our pipeline is fueled by external innovation and supported by nearly 100 years of development experience and global hubs in the U.S., France and the U.K. Our teams in more than 40 countries and our partnerships around the world enable us to bring medicines to patients in more than 80 countries.

我们的渠道由外部创新推动，并由近100年的发展经验和美国、法国和英国的全球中心提供支持。我们在40多个国家的团队和我们在世界各地的合作伙伴使我们能够为80多个国家的患者提供药物。

Ipsen is listed in Paris (Euronext: IPN) and in the U.S. through a Sponsored Level I American Depositary Receipt program (ADR: IPSEY). For more information, visit ipsen.com.

Ipsen通过赞助的一级美国存托凭证计划（ADR：IPSEY）在巴黎（泛欧交易所：IPN）和美国上市。有关更多信息，请访问ipsen.com。

Ipsen contacts

Ipsen联系人

Investors

投资者

Nicolas Bogler | + 33 6 52 19 98 92

尼古拉斯·博格勒+33 6 52 19 98 92

Media

媒体

Jennifer Smith-Parker | + 44 7843 13 77 64 | jennifer.smith-parker.ext@ipsen.com

詹妮弗·史密斯·帕克|+44 7843 13 77 64|jennifer.smith-parker.ext@ipsen.com

Rachel Reiff | + 1 908 616 1680 | rachel.reiff@ipsen.com

雷切尔·雷夫+1 908 616 1680|rachel.reiff@ipsen.com

Anna Gibbins | + 44 7717 80 19 00| anna.gibbins@ipsen.com

安娜·吉宾斯|+44 7717 80 19 00|anna.gibbins@ipsen.com

Disclaimers and/or Forward-Looking Statements

免责声明和/或前瞻性声明

The forward-looking statements, objectives and targets contained herein are based on Ipsen’s management strategy, current views and assumptions. Such statements involve known and unknown risks and uncertainties that may cause actual results, performance or events to differ materially from those anticipated herein.

本文所含的前瞻性声明、目标和指标基于Ipsen的管理战略、当前观点和假设。此类声明涉及已知和未知的风险和不确定性，可能导致实际结果、绩效或事件与本文预期的结果、绩效或事件产生重大差异。

All of the above risks could affect Ipsen’s future ability to achieve its financial targets, which were set assuming reasonable macroeconomic conditions based on the information available today. Use of the words ‘believes’, ‘anticipates’ and ‘expects’ and similar expressions are intended to identify forward-looking statements, including Ipsen’s expectations regarding future events, including regulatory filings and determinations.

所有上述风险都可能影响Ipsen未来实现财务目标的能力，这些目标是根据现有信息在合理的宏观经济条件下设定的。使用“相信”、“预期”和“预期”等词语以及类似的表述旨在识别前瞻性陈述，包括Ipsen对未来事件的预期，包括监管备案和决定。

Moreover, the targets described in this document were prepared without taking into account external-growth assumptions and potential future acquisitions, which may alter these parameters. These objectives are based on data and assumptions regarded as reasonable by Ipsen. These targets depend on conditions or facts likely to happen in the future, and not exclusively on historical data.

此外，本文件中描述的目标是在没有考虑外部增长假设和潜在的未来收购的情况下制定的，这可能会改变这些参数。这些目标基于Ipsen认为合理的数据和假设。这些目标取决于未来可能发生的情况或事实，而不仅仅取决于历史数据。

Actual results may depart significantly from these targets given the occurrence of certain risks and uncertainties, notably the fact that a promising medicine in early development phase or clinical trial may end up never being launched on the market or reaching its commercial targets, notably for regulatory or competition reasons.

考虑到某些风险和不确定性的发生，实际结果可能与这些目标有很大差距，特别是在早期开发阶段或临床试验中有前途的药物可能永远不会上市或达到其商业目标，特别是出于监管或竞争原因。

Ipsen must face or might face competition from generic medicine that might translate into a loss of market share. Furthermore, the research and development process involves several stages each of which involves the substantial risk that Ipsen may fail to achieve its objectives and be forced to abandon its efforts with regards t.

。此外，研究和开发过程涉及几个阶段，每个阶段都涉及Ipsen可能无法实现其目标并被迫放弃其在t方面的努力的重大风险。

References

1.Kowdley. K,. et al. Long term efficacy and safety of elafibranor in primary biliary cholangitis: Interim results from the open-label extension of the ELATIVE® trial up to 3 years . Poster, Abstract 5041. American Association for the Study of Liver Disease (AASLD).20242.Swain. M, et al. Impact of elafibranor on fatigue in patients with primary biliary cholangitis: Interim results from the long-term open-label extension of the ELATIVE® trial .

1.科德利。K、 ，。elafibranor治疗原发性胆汁性胆管炎的长期疗效和安全性：ELATIVE®试验开放标签延长至3年的中期结果。。美国肝病研究协会（AASLD）。20242.Swain。M、 elafibranor对原发性胆汁性胆管炎患者疲劳的影响：ELATIVE®试验长期开放标签延长的中期结果。

Poster, Abstract 5042. American Association for the Study of Liver Disease (AASLD).20243Lu M, Zhou, et al. Fibrotic Liver Disease Consortium Investigators. Increasing Prevalence of Primary Biliary Cholangitis and Reduced Mortality With Treatment. Clin Gastroenterol Hepatol. 2018 Aug;16(8):1342-1350.e1.

海报，摘要5042。美国肝病研究协会（AASLD）。20243Lu M，Zhou等人。纤维化肝病协会研究人员。原发性胆汁性胆管炎的患病率增加，治疗死亡率降低。临床胃肠肝病。2018年8月；16（8）：1342-1350.e1。

DOI: 10.1016/j.cgh.2017.12.033..

DOI:10.1016/j.cgh.2017.12.033。。

Attachment

附件

Ipsen PR_Iqirvo® (elafibranor) data shows efficacy and safety for up to 3 years_15112024

Ipsen PR\u Iqirvo®（elafibranor）的数据显示了长达3年的疗效和安全性\u 15112024