胰岛素(安万特制药公司)。
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琼斯R
胰岛素(安万特制药公司)。
IDrugs。2000年9月;3 (9):1081 - 7。
- PubMed ID
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16049868 (在PubMed]
- 文摘
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胰岛素是一种生物合成人胰岛素模拟,开发了安万特制药公司(以前,赫斯特马里恩Roussel HMR),第一种和第二种糖尿病的治疗。1999年4月,地特胰岛素HMR提起批准在欧洲和美国[322507]。2000年4月,FDA批准了胰岛素(用来)治疗成人2型糖尿病患者,他们需要基础胰岛素控制高血糖,对成人和儿童1型糖尿病患者[363836]。安内特推出这款产品预计在2000年[361988]。2000年6月,EMEA批准胰岛素治疗I和II型糖尿病[370984]。1999年4月,FDA建议HMR应该最初提交6个月疗效和安全性数据,而不是通常的12月的数据,加快FDA批准程序。其余的三期数据将被添加到文件[279466]在稍后的日期。胰岛素在三期试验在日本作为基础胰岛素替代治疗I型糖尿病[216445]。两个配方的胰岛素锌也已进行第一阶段试验。锄头- 71 / GT15和GT80包含15和80μg / ml的锌。 These formulations appear to have longer duration of action with a reduced peak insulin effect [177507]. This insulin analog has a lower receptor binding affinity compared with human insulin, but shows equal potency in vivo [320724]. Insulin glargine was designated as a medium priority project by HMR, which means the project had been set tight deadlines which if not achieved, would have resulted in discontinuation [221118]. In April 2000, Novo Nordisk filed a complaint in Germany against Aventis claiming that the production and sale of insulin glargine infringes two German patents held by Novo Nordisk [364362]. In July 2000, Credit Lyonnais Securities Europe predicted that insulin glargine was likely to enjoy a strong competitive position for several years in Europe and the US, following launch in these territories during 2000, while it was predicted that a registration dossier would be submitted in Japn in 2002. Sales were predicted to reach Euro 600 million by 2005. In April 1999, ABN Amro predicted annual sales of DM 75 million in 2000, rising to DM 200 million in 2002 [328676].
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