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诺华在欧洲推出雷珠单抗Lucentis预充注射剂

发布时间:2014年03月22日 17:57:03

诺华(Novartis)3月20日宣布,在德国推出诺适得(Lucentis,通用名:雷珠单抗,ranibizumab)预充注射剂,该产品将于2014年在欧洲其他市场上市。预充式注射器配方,专门设计用于眼内注射,以加强患者的安全和临床医生的便利。

 

Lucentis预充式注射剂诸多优势,如可提供更高的剂量准确性和更方便的治疗过程,同时,不可缩回式柱塞可降低非无菌条件下不良事件的风险。这些特性有望减少治疗等待时间,改善患者的治疗经历。

 

Lucentis是一种人源化的治疗性抗体片段,旨在阻断所有生物活性形式的血管内皮细胞生长因子A(VEGF-A),该因子的水平在湿性AMD和其他眼科疾病(如糖尿病性黄斑水肿(DME)、视网膜静脉阻塞(RVO))升高。Lucentis专门设计用于眼部,使系统性暴露(systemic exposure)最小化。

 

目前,Lucentis已获100多个国家批准,用于治疗湿性年龄相关性黄斑变性(wet-AMD)、糖尿病性黄斑水肿(DME)所致的视力损害、视网膜静脉阻塞(RVO)继发黄斑水肿(macular edema)所致的视力损害。此外,Lucentis已获40多个国家批准,用于病理性近视继发脉络膜新生血管(myopic CNV)引发的视力损害。

 

Lucentis于2006年上市,由罗氏(Roche)旗下基因泰克(Genentech)和诺华合作开发,是诺华的一个重要产品,罗氏拥有Lucentis在美国的商业化权利,诺华则拥有该药在美国以外国家和地区的独家权利。

 

Novartis Launches Lucentis Prefilled Syringe in Europe

 

3/20/2014 2:32 AM ET

 

Novartis AG (NVS: Quote) Thursday announced the launch of the Lucentis or ranibizumab pre-filled syringe in Germany, with other markets to follow throughout 2014.

 

The Lucentis pre-filled syringe or PFS, which received European approval in October 2013, is a new way of administering Lucentis that is specifically designed for intraocular injection to enhance patient safety and convenience for the treating clinician.

 

David Epstein, Division Head, Novartis Pharmaceuticals, said, ''We are pleased to be able to offer a better way to accurately and safely administer Lucentis in the eye. Lucentis PFS brings convenience, safety, and the potential for improved efficiency and dose accuracy to both retinal specialists and patients."

 

The Lucentis PFS has been specifically designed to reduce the risk of adverse events to patients and to enhance the treatment process in the clinic. This new injection technology offers the potential for improved safety for patients through a reduction in non-sterile preparatory steps and the inclusion of more safety features, such as a non-retractable plunger. Moreover, greater dose accuracy is possible through design features such as a smaller syringe barrel.

 

According to the company, these features combined may equate to reduced waiting times and thereby improve the patient treatment experience.

 

 

 

 

 

 

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