诺华在欧洲推出Lucentis预充注射剂

2014-03-21 tomato 生物谷

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

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。

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    2014-03-23 zchen

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