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辉瑞公司的选择性血管内皮生长因子(VEGF)抑制剂哌加他尼钠(pegaptanib sodium,Macugen)已获欧洲批准,用于治疗所有类型的年龄相关性湿性黄斑变性。Macugen在2005年9月就获得了欧盟肯定的意见,但由于该产品在美国上市后有过敏性报道而使许可延迟了。Macugen是首个用于治疗急性黄斑变性(AMD)的血管内皮生长因子,美国和欧盟的批准它是基于临床有效性的数据。在治疗54周后,接受Macugen的患者中视敏度减退少于3行(视力表)的比例小于安慰剂组。然而,Macugen仅能延缓视力减退,而其竞争产品——诺华／基因技术公司的兰尼单抗(ranibizum- ab,Lucenfis)能改善视敏度,这个产品正在美国申请上市。
Pfizer’s selective vascular endothelial growth factor (VEGF) inhibitor pegaptanib sodium (Macugen) has been approved in Europe for the treatment of all types of age-related wet macular degeneration. Macugen won the EU’s positive opinion in September 2005, but delays in licensing due to the allergy reported after the product was listed in the United States. Macugen is the first vascular endothelial growth factor used to treat acute macular degeneration (AMD). The United States and the European Union have approved it as clinically validated data. After 54 weeks of treatment, less than 3 lines of visual acuity (visual acuity) were reduced in patients receiving Macugen compared with placebo. However, Macugen can only slow vision loss while its competing product, ranibizumab (Lucenfis) from Novartis / Genentech, improves visual acuity and is on the US market.