CHMP推荐在欧盟批准Oczyesa®用于治疗肢端肥大症-动脉网

CHMP recommends approval of Oczyesa® for treatment of acromegaly in the EU

CISION 等信源发布 2025-04-25 22:20

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LUND, Sweden

瑞典隆德

，

April 25, 2025

2025年4月25日

/PRNewswire/ -- Camurus (NASDAQ STO: CAMX) today announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for market authorization of Oczyesa

/PRNewswire/ -- Camurus（纳斯达克股票代码：CAMX）今天宣布，欧洲药品管理局人用药品委员会（CHMP）已采纳对Oczyesa上市授权的积极意见。

, octreotide subcutaneous depot (CAM2029), for the maintenance treatment in adult patients with acromegaly who have responded to and tolerated treatment with somatostatin analogues.

，奥曲肽皮下贮库制剂（CAM2029），用于对生长抑素类似物治疗有反应并耐受的成年肢端肥大症患者的维持治疗。

'We are pleased with the CHMP's positive recommendation for market authorization for Oczyesa octreotide monthly depot for the treatment of acromegaly', says

“我们对CHMP对Oczyesa奥曲肽每月一次长效制剂治疗肢端肥大症的上市授权积极推荐感到满意”，

Fredrik Tiberg

弗雷德里克·蒂贝里

, President & CEO at Camurus. 'Oczyesa has the potential to advance the standard of care for patients living with acromegaly by enhancing octreotide plasma exposure and enabling easy and convenient once-monthly self-administration by patients using an autoinjector pen.'

，Camurus公司总裁兼首席执行官。“Oczyesa有望通过提高奥曲肽的血浆暴露水平，并通过使用自动注射笔让患者方便快捷地每月一次自我给药，从而提升肢端肥大症患者的生活质量。”

The CHMP positive opinion is backed by a comprehensive clinical program comprising seven clinical studies, including two Phase 3 studies. The ACROINNOVA 1 study demonstrated that treatment with Oczyesa results in a significantly higher proportion of patients achieving normalized insulin growth-factor-1 (IGF-1) levels compared to placebo.

CHMP的积极意见得到了一个包含七项临床研究的全面临床项目的支持，其中包括两项III期研究。ACROINNOVA 1研究表明，与安慰剂相比，使用Oczyesa治疗可显著提高胰岛素样生长因子-1（IGF-1）水平正常化的患者比例。

The persistence of mean IGF-1 values and reduction of symptoms were confirmed over 52 weeks in the ACROINNOVA 2 study. Furthermore, the study showed improvements in symptoms, quality of life, and treatment satisfaction scores after 52 weeks of treatment with Oczyesa compared to standard of care (SoC) at study baseline..

在ACROINNOVA 2研究中，平均IGF-1值的持续性和症状的减轻在52周内得到了证实。此外，研究显示，与研究开始时的标准治疗（SoC）相比，使用Oczyesa治疗52周后，症状、生活质量和治疗满意度评分均有所改善。

2,3

The most common side effects included gastrointestinal disorders, nervous system disorders, hepatobiliary disorders, metabolism and nutritional disorders, and injection site reactions.

最常见的副作用包括胃肠道疾病、神经系统疾病、肝胆疾病、代谢和营养障碍，以及注射部位反应。

A final decision on the marketing authorization of Oczyesa based on the CHMP recommendation is anticipated from the European Commission in mid-2025.

预计欧洲委员会将于2025年年中根据CHMP的建议对Oczyesa的上市授权做出最终决定。

For more information

更多信息请参见

Fredrik Tiberg

弗雷德里克·蒂贝里

, President & CEO

，总裁兼首席执行官

Tel. +46 (0)46 286 46 92

电话：+46 (0)46 286 46 92

fredrik.tiberg@camurus.com

Fredrik Joabsson, Chief Business Development Officer

弗雷德里克·乔亚布森，首席业务发展官

Tel. +46 (0)70 776 17 37

电话：+46 (0)70 776 17 37

ir@camurus.com

About acromegaly

关于肢端肥大症

Acromegaly is a rare, progressive disease, typically caused by a tumor of the pituitary gland producing excess growth hormone and stimulating increased insulin growth factor-1 (IGF-1) levels. This results in abnormal growth of bone and tissue, enlarged hands, feet, facial features and inner organs, and symptoms such as fatigue, joint pain, headache, visual field defects, excessive sweating, and paresthesia..

肢端肥大症是一种罕见的、进行性疾病，通常由垂体肿瘤引起，该肿瘤产生过量的生长激素并刺激胰岛素样生长因子-1（IGF-1）水平升高。这会导致骨骼和组织异常增长，手、脚、面部特征及内脏器官增大，并伴随疲劳、关节疼痛、头痛、视野缺损、过度出汗和感觉异常等症状。

Inadequate biochemical and symptom control can have detrimental impacts on quality of life and mortality of patients with acromegaly.

生化控制和症状控制不足可能对肢端肥大症患者的生活质量和死亡率产生不利影响。

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The prevalence of acromegaly is estimated to about 60 cases per million.

肢端肥大症的患病率估计约为每百万人口中有60例。

About Oczyesa

关于Oczyesa

(CAM2029)

CAM2029 is a ready-to-use, long-acting subcutaneous depot of octreotide under development for the treatment of three chronic and severe disease indications: acromegaly, gastroenteropancreatic neuroendocrine tumors (GEP-NET), and polycystic liver disease (PLD).

CAM2029 是一种即用型、长效的奥曲肽皮下贮库制剂，正在开发用于治疗三种慢性且严重的疾病：肢端肥大症、胃肠胰神经内分泌肿瘤 (GEP-NET) 和多囊性肝病 (PLD)。

The CAM2029 clinical program for acromegaly comprises of seven clinical trials, including four Phase 1 studies, one Phase 2 study, and two Phase 3 studies within the ACROINNOVA clinical program. CAM2029 has demonstrated an approximate five-fold higher bioavailability compared to the currently approved, long-acting, intramuscular (IM) octreotide..

CAM2029针对肢端肥大症的临床项目包括七项临床试验，其中包括四项I期研究、一项II期研究和两项在ACROINNOVA临床项目下的III期研究。CAM2029的生物利用度比目前获批的长效肌肉注射（IM）奥曲肽高出约五倍。

In the Phase 3 ACROINNOVA program, CAM2029 showed superior biochemical control compared to placebo as well as improvements in symptom control, treatment satisfaction, and quality of life compared to standard-of-care (SoC) at baseline with first-generation somatostatin receptor ligands (SRLs), octreotide and lanreotide.

在三期ACROINNOVA项目中，CAM2029相较于安慰剂展现了更优的生化控制，并且在症状控制、治疗满意度和生活质量方面较基线使用第一代生长抑素受体配体（SRLs）奥曲肽和兰瑞肽的标准治疗（SoC）有所改善。

The safety profile of CAM2029 was consistent with SoC with no new findings..

CAM2029 的安全性与标准治疗 (SoC) 一致，没有新的发现。

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CAM2029 is formulated using Camurus' proprietary FluidCrystal

CAM2029是使用Camurus专有的FluidCrystal技术配制的。

technology. The product is designed for convenient once-monthly, subcutaneous self-administration using a pen with a hidden, small-gauge needle. The product is stored at room temperature and should not be refrigerated.

技术。该产品设计用于每月一次的皮下自我注射，使用带有隐藏的小规格针头的笔进行操作。该产品应存放在室温下，不应冷藏。

CAM2029 has received orphan drug designation for acromegaly (EU) and for polycystic liver disease (EU and US).

CAM2029 已获得用于肢端肥大症（欧盟）和多囊性肝病（欧盟和美国）的孤儿药资格认定。

About Camurus

关于Camurus

Camurus is an international, science-led biopharmaceutical company committed to developing and commercializing innovative, long-acting medicines for improving the lives of patients with severe and chronic diseases. New drug products with best-in-class potential are conceived based on the company's proprietary FluidCrystal.

Camurus是一家国际性的、以科学为引领的生物制药公司，致力于开发和商业化创新的长效药物，以改善重度和慢性疾病患者的生活。公司基于其专有的FluidCrystal技术，构想出具有同类最佳潜力的新药产品。

technology and its extensive R&D expertise. The R&D pipeline includes products for the treatment of dependence, pain, cancer, and endocrine diseases. Camurus has operations across

技术和其广泛的研發專業知識。研發管線包括用於治療依賴性、疼痛、癌症和內分泌疾病的產品。 Camurus的業務遍及

Europe

欧洲

, the US, and

、美国，以及

Australia

澳大利亚

, with headquarters in

，总部位于

Lund, Sweden

瑞典隆德

. The company's shares are listed on Nasdaq Stockholm under the ticker CAMX. For more information, visit

公司的股票在纳斯达克斯德哥尔摩上市，股票代码为CAMX。欲了解更多信息，请访问

www.camurus.com

and

和

领英

。

References

参考文献

Oczyesa

奥奇耶萨

Summary of Opinion.

意见摘要。

Ferone, D., et al. J Clin Endocrinol Metab. Published

费罗内，D. 等。《临床内分泌与代谢杂志》。已发表

8 October, 2024

2024年10月8日

。

Press release

新闻稿

15 July, 2024

2024年7月15日

：

https://www.camurus.com/media/press-releases/2024/camurus-announces-positive-phase-3-results-from-the-acroinnova-2-study-of-octreotide-sc-depot-cam2029-in-acromegaly-patients/

Colao A., et al. Acromegaly. Nat Rev Dis Primers. 2019;5(1):20.

科拉奥 A. 等。肢端肥大症。《自然综述：疾病导论》。2019；5(1):20。

Webb SM, et al. Quality of Life in Acromegaly. Neuroendocrinology. 2016;103(1):106-111.

Webb SM，等。肢端肥大症患者的生活质量。《神经内分泌学》。2016；103（1）：106-111。

Fleseriu M, et al Acromegaly: pathogenesis, diagnosis, and management. Lancet Diabetes Endocrinol. 2022 Nov;10(11):804-826.

Fleseriu M, 等肢端肥大症：发病机制、诊断与管理。《柳叶刀糖尿病与内分泌学》2022年11月；第10卷第11期：804-826页。

Crisafulli S., et al. Global epidemiology of acromegaly: a systematic review and meta-analysis. Eur J Endocrinology. 2021; 185:251-63.

Crisafulli S. 等。全球肢端肥大症流行病学：一项系统综述与荟萃分析。《欧洲内分泌学杂志》。2021年；185:251-63。

Summary of Product Characteristics, Sandostatin LAR 20 mg:

产品特性摘要，Sandostatin LAR 20 mg：

https://assets.hpra.ie/products/Human/22656/Licence_PA0896-028-005_03012024152159.pdf

This information was submitted for publication at