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【drug-news】吸入型胰岛素可能导致肺癌
US drugmakers Pfizer Inc and Nektar Therapeutics on Wednesday warned of cases of lung cancer in clinical trials of their inhaled insulin Exubera.
The findings led Nektar to announce it was abandoning its search for a new marketing partner for the troubled drug, effectively signaling Exubera's demise after entering the market in January 2006.
Pfizer, the world's largest pharmaceutical company, announced last October it stopped marketing Exubera, saying it did not meet customer needs or the financial expectations of the company.
The rise in lung cancer apparently linked to Exubera led Pfizer to update the medication's warning label to include information "about lung cancer cases observed in patients who used Exubera," the company reported in a statement.
It said that over the course of the clinical trial, six out of 4,740 Exubera-treated patients developed lung cancer, versus one of the 4,292 patients not treated with Exubera.
An additional case of lung cancer in an Exubera-treated patient was discovered after the drug's debut on the market following its approval by the US Food and Drug Administration.
The updated label states that all patients who developed lung cancer had a prior history of cigarette smoking, and that there were "too few cases to determine whether the development of lung cancer is related to the use of Exubera."
"Some patients continue to take Exubera, including those enrolled in extended transition programs or clinical trials," Pfizer chief medical officer Joe Feczko said in the statement.
"We are working closely with patients and their physicians to ensure the continued orderly transition from Exubera to alternative therapies," he added.
Nektar announced it was stopping all spending on the drug, including research and marketing.
"The concern over this new data analysis from ongoing clinical trials has resulted in the termination of all negotiations with potential partners," said Nektar president Howard Robin on the company's website.
Diabetes affects 230 million people worldwide, including 21 million in the United States, according to Pfizer. Exubera is a short-acting insulin breathed in through an inhaler that helps control high blood sugar in people with diabetes.
http://news.sg.msn.com/topstories/article.aspx?cp-documentid=1334166
三大巨头放弃吸入型胰岛素时均宣称并非由于安全性因素，现在看来肺部给药仍需谨慎。对Nektar影响也很大，不能再找合作伙伴开发Exubra，全面放弃。不知道对MannKind有何影响，吸入胰岛素的最后一家 本人已认领该文编译，48小时后若未提交译文，请其他战友自由认领。 Pfizer warns of lung cancer link with inhaled insulin
辉瑞提醒吸入型胰岛素可能导致肺癌
US drugmakers Pfizer Inc and Nektar Therapeutics on Wednesday warned of cases of lung cancer in clinical trials of their inhaled insulin Exubera.
美国辉瑞制药公司 和Nektar Therapeutics公司警告他们的喷吸胰岛素 Exubera可能导致肺癌
The findings led Nektar to announce it was abandoning its search for a new marketing partner for the troubled drug, effectively signaling Exubera's demise after entering the market in January 2006.
这个结论导致Nekta宣布放弃为这个麻烦的药物寻找新的市场合作伙伴，这意味从2006年进入市场以后， Exubera已完全失败。
Pfizer, the world's largest pharmaceutical company, announced last October it stopped marketing Exubera, saying it did not meet customer needs or the financial expectations of the company.
美国辉瑞，国际制药业的巨头，去年10月辉瑞宣布停止销售Exubera,说Exubera或者不能被病人所接受或不能为公司创造足够的经济利益。
The rise in lung cancer apparently linked to Exubera led Pfizer to update the medication's warning label to include information "about lung cancer cases observed in patients who used Exubera," the company reported in a statement.
公司宣称，肺癌的发病率上升明显与 Exubera相关，公司已更新了药物警告的标签包括：“使用Exubera的患者发现了肺癌病例。”
It said that over the course of the clinical trial, six out of 4,740 Exubera-treated patients developed lung cancer, versus one of the 4,292 patients not treated with Exubera.
据说在Exubera临床试验过程中，在4740 Exubera治疗的患者中，有6人出现了肺癌，而对照组4292人中只有1人。
An additional case of lung cancer in an Exubera-treated patient was discovered after the drug's debut on the market following its approval by the US Food and Drug Administration.
当FDA Exubera开始进入市场后，另外一例肺癌也被发现，。
The updated label states that all patients who developed lung cancer had a prior history of cigarette smoking, and that there were "too few cases to determine whether the development of lung cancer is related to the use of Exubera."
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作者:admin@医学,生命科学 2011-01-26 05:14
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