2007年8月31日,美国FDA批准法国益普生(Ipsen)公司的兰瑞肽(lanreotide)储库型控释注射剂(商品名:Somatuline Depot)作为NME上市,用于长期治疗不宜手术和(或)放疗的肢端肥大症患者。本品为预填充注射器,不需复溶,因而可非常方便地用于患者。剂量规格:兰瑞肽60 mg/支,90 mg/支,120 mg/支。 Somatuline Depot(在美国外的商品名为Somatuline Autogel)为含有抑制生长激素释放的生长激素释放抑制因子同系物兰瑞肽。本品初始开发且目前继续主要用于治疗肢端肥大症(由垂体前叶良性肿瘤引起生长激素或泌乳素产生过度造成的疾病)。此药品正在欧洲开发用于治疗神经内分泌瘤(尤其是类癌型)引起的症状。益普生公司认为Somatuline Autogel拥有的技术代表了重大技术发展。因兰瑞肽本身可控制缓缓释出药物,故本品是第一个除水外无任何辅料的半固体注射剂,可持续释药28日,一月1次,而原制剂需2~3次。 Somatuline Depot Lanreotide acetate (Somatuline Depot Injection, Tercica) has been approved for the treatment of acromegaly, a rare and potentially life-threatening disease in adults. Abnormal secretion of growth hormone drags (GH) is commonly caused by a benign tumor in the pituitary gland. This new treatment lowers the levels of certain hormones in the body, including GH and insulin-like growth factor. Excessive GH secretion can cause en generic largement of the hands, feet, facial bones, and internal organs such as the heart and liver. If untreated, patients with acromegaly often have a shortened life span because of heart and respiratory diseases, diabetes mellitus, and colon cancer. The safety and effectiveness of the product was determined in two pivotal clinical trials involving 400 patients. |
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治疗内分泌代谢疾病的新药—Somatuline Depot(兰瑞肽控释注射剂)简介:
2007年8月31日,美国FDA批准法国益普生(Ipsen)公司的兰瑞肽(lanreotide)储库型控释注射剂(商品名:Somatuline Depot)作为NME上市,用于长期治疗不宜手术和(或)放疗的肢端肥大症患者。本品为预填充注射器 ... 责任编辑:admin |
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