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拜耳Eylea新适应症获日本批准

  1. aflibercept
  2. Eylea
  3. 拜耳
  4. 视网膜中央静脉阻塞
  5. 阿伯西普
  6. 黄斑水肿

来源:生物谷 2013-11-25 09:30

拜耳眼科药物Eylea获日本批准,用于视网膜中央静脉阻塞(CRVO)继发黄斑水肿(ME)的治疗,该药是一种新型玻璃体内注射用VEGF抑制剂,已获批用于新生血管性年龄相关性黄斑变性(wet-AMD)的治疗。

2013年11月25日讯 /生物谷BIOON/ --拜耳(Bayer)11月22日宣布,眼科药物Eylea(aflibercept,阿柏西普注射液)已获日本卫生劳动福利部(MHLW)批准,用于视网膜中央静脉阻塞(CRVO)继发黄斑水肿(ME)的治疗。

目前,Eylea已获欧洲、美国、日本、澳大利亚及其他国家批准,用于新生血管性年龄相关性黄斑变性(wet-AMD)的治疗。此外,Eylea于今年8月获欧盟(EC)批准,用于治疗视网膜中央静脉阻塞(CRVO)继发黄斑水肿(ME)所致的视力损害,同时已获美国及亚洲、非洲特定国家批准用于治疗CRVO继发ME。

Eylea是一种新型玻璃体内注射用VEGF抑制剂,是一种重组融合蛋白,由人体血管内皮细胞生长因子(VEFG)受体1和2的胞外区与人体免疫球蛋白G1的可结晶片段融合而成。

Eylea作为VEGF家族各成员(包括VEGF-A)及胎盘生长因子(PIGF)的一种可溶性诱饵受体发挥作用,与这些因子具有极高的亲和力,从而抑制这些因子与同源VEGF受体的结合,因此Eylea可抑制异常的血管生成及渗漏。

目前,拜耳和Regeneron正在合作Eylea的全球开发。Regeneron保留Eylea在美国的独家权利,拜耳则授权获得该药在美国以外国家和地区的独家销售权,这2家公司将平分Eylea在未来销售的利润。(生物谷Bioon.com)

英文原文:Bayer Receives Approval for EYLEA? in Japan for the Treatment of Macular Edema Secondary to Central Retinal Vein Occlusion

Berlin, November 22, 2013 – Bayer HealthCare has received approval from the Ministry of Health, Labour and Welfare (MHLW) in Japan for EYLEA? (aflibercept solution for injection) for the treatment of macular edema secondary to central retinal vein occlusion (CRVO).

“The additional approval of EYLEA in Japan for the treatment of macular edema secondary to CRVO is great news for patients in Japan suffering from this potentially sight-threatening eye condition,” said Kemal Malik, M.D., Member of the Bayer HealthCare Executive Committee and Head of Global Development. “The loss of vision not only impacts patients but also their families’ lives.”

VEGF Trap-Eye has been approved under the brand name EYLEA? in Europe, the United States, Japan, Australia, and in many other countries for the treatment of patients with neovascular age-related macular degeneration (wet AMD). EYLEA has also been approved in Europe for the treatment of visual impairment due to macular edema secondary to CRVO as well as in the U.S. and in selected countries in Asia and Latin America for the treatment of macular edema following CRVO.

Bayer HealthCare and Regeneron Pharmaceuticals, Inc. are collaborating on the global development of EYLEA. Regeneron maintains exclusive rights to EYLEA in the United States. Bayer HealthCare licensed the exclusive marketing rights outside the United States, where the companies share equally the profits from sales of EYLEA, except for Japan where Regeneron receives a royalty on net sales.

About Central Retinal Vein Occlusion (CRVO)

Over 66,000 people in major European countries, more than 100,000 people in the United States, and about 140,000 patients in Japan, over the age of 40 are estimated to suffer from CRVO. CRVO is caused by obstruction of the central retinal vein that leads to an accumulation of deoxygenated blood and fluid in the retina. Macular edema secondary to CRVO causes retinal damage and loss of vision. Release of vascular endothelial growth factor (VEGF) contributes to increased vascular permeability in the eye and macular edema. It has been shown that anti-VEGF treatment helps decrease vascular permeability and edema in the retina in patients with CRVO.

About VEGF and EYLEA? (aflibercept solution for injection)

Vascular Endothelial Growth Factor (VEGF) is a naturally occurring protein in the body. Its normal role in a healthy organism is to trigger formation of new blood vessels (angiogenesis) supporting the growth of the body's tissues and organs. However, in certain diseases, it is associated with the growth of abnormal new blood vessels in the eye, which exhibit abnormal increased permeability that leads to edema in certain diseases of the retina. Scarring and loss of fine-resolution central vision often results. In Central Retinal Vein Occlusion (CRVO), a blockage occurs in the main blood vessel that transports deoxygenated blood away from the retina. VEGF levels are elevated in response contributing to macular edema.

EYLEA? is a recombinant fusion protein, consisting of portions of human VEGF receptors 1 and 2 extracellular domains fused to the Fc portion of human IgG1 and formulated as an iso-osmotic solution for intravitreal administration. EYLEA acts as a soluble decoy receptor that binds VEGF-A and placental growth factor (PlGF) and thereby can inhibit the binding and activation of these cognate VEGF receptors.

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