诺华Lucentis获日本批准用于DME治疗

关键词:诺华,Lucentis,雷珠单抗,糖尿病性黄斑水肿

2014年2月22日讯 /生物谷BIOON/ --诺华(Novartis)2月21日宣布,眼科药物诺适得(Lucentis,通用名:雷珠单抗,ranibizumab)获日本批准,用于治疗糖尿病性黄斑水肿(DME)所致的视力损害。该药是日本批准用于DME治疗的首个抗VEGF疗法。同时,DME也是Lucentis在日本获批的第4个适应症。

目前,在日本,激光治疗是DME的标准疗法。激光治疗能稳定视力,但通常并不会提高视力。Lucentis是首个获批可显著改善亚洲DME患者视力的药物。

Lucentis DME适应症的获批,是基于III期REVEAL试验的数据。REVEAL是首个专门评估Lucentis用于亚洲DME患者的疗效和安全性试验,涉及来自6个国家396例DME患者。

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,该药在2012年的销售额达到了24亿美元,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。(生物谷Bioon.com)

英文原文:Novartis shows continued commitment in Japan with Lucentis? approval in fourth Japanese indication, diabetic macular edema(DME)

—Lucentis is the first anti-VEGF therapy approved for diabetic macular edema (DME) in Japan

—Pivotal clinical data in Asian patients show a significant increase in mean visual acuity following treatment with Lucentis compared with laser therapy[1]

—Diabetic macular edema is a leading cause of blindness in most developed countries in the working-age population[2]

Basel, February 21, 2014 - Lucentis? (ranibizumab) has been approved by Japanese regulatory bodies for a fourth indication: the treatment of patients with diabetic macular edema (DME), a leading cause of vision loss among patients with diabetes. Laser therapy, the current standard of care in Japan, has provided stabilization of vision in many patients, but generally does not improve vision. Lucentis is the first licensed therapy to significantly improve vision in Asian patients with visual impairment due to DME.

"Lucentis has previously been shown to be an effective treatment, improving vision loss and vision-related quality of life for patients with DME," said Tim Wright, Global Head of Development, Novartis Pharmaceuticals. "Now Japanese patients living with DME have access to Lucentis, a drug with an unsurpassed efficacy and safety profile across multiple indications."

Approval of Lucentis was based on results from the REVEAL trial, the first randomized clinical trial specifically designed to assess the efficacy and safety of Lucentis in Asian patients with visual impairment due to DME. In this Phase III trial, 396 patients from six countries, including Japan, were initially treated with monthly injections of 0.5 mg Lucentis, 0.5 mg Lucentis plus laser treatment or laser treatment alone for two months. Treatment was continued for twelve months if stable vision was not reached[1].

Efficacy and safety results from the REVEAL study were similar to other DME trials primarily conducted in Caucasians[3],[4]. At twelve months, REVEAL confirmed the superior efficacy of Lucentis with rapid and sustained visual acuity gains compared with laser therapy. Safety results showed that Lucentis was well tolerated in patients with DME both as monotherapy or when administered together with laser[1].

Diabetic macular edema is a consequence of diabetic retinopathy, the most common diabetic eye complication. DME is characterized by changes in the blood vessels of the retina, which is the light-sensitive layer at the back of the eye. In patients with DME, leakage from these abnormal blood vessels occurs in the central portion of the retina, called the macula. Because this part of the eye is responsible for sharp central vision, DME can lead to significant visual impairment. Visual impairment due to DME affects approximately 1-3% of patients with diabetes, and DME is a leading cause of blindness in the working-age population in most developed countries[2].

About Lucentis? (ranibizumab)
Lucentis was designed to save sight and has demonstrated transformational efficacy with individualized dosing in its licensed indications. As an antibody fragment with a short systemic half-life, Lucentis was specifically designed, developed, formulated and licensed for ocular conditions, and is manufactured to the highest standards for intra-ocular use.

Lucentis is licensed in more than 100 countries, for the treatment of wet AMD, visual impairment due to DME and for visual impairment due to macular edema secondary to RVO, including both branch- and central-RVO. Also, Lucentis is licensed in more than 40 countries for the treatment of patients with visual impairment due to CNV secondary to pathologic myopia (myopic CNV). In most countries, including those in Europe, Lucentis has an individualized treatment regimen with the goal of maximizing visual outcomes while minimizing under- or over-treating patients.

Lucentis has a well-established safety profile supported by 43 extensive sponsored clinical studies and real-world experience. Its safety profile has been well established in a clinical development program that enrolled more than 12,500 patients across indications and there is more than 2.2 million patient-treatment years of exposure since its launch in the United States in 2006.

Lucentis was developed by Genentech and Novartis. Genentech has the commercial rights to Lucentis in the United States. Novartis has exclusive rights in the rest of the world. Lucentis is a registered trademark of Genentech Inc.

(责任编辑:lishuheng)

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