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【drug-news】Vivus答复了FDA关于减肥药Qnexa 的疑虑
Vivus has responded to the US Food and Drug Administration’s complete response letter regarding its application to market Qnexa as a treatment for obesity and weight loss.
The company has submitted a briefing document to agency addressing the various concerns it had with the New Drug Application, and also announced that it has been grated a meeting with the FDA’s Endocrine and Metabolic Division in the second half of January to discuss its proposed resubmission.
Vivus is seeking to market Qnexa (phentermine/topiramate) controlled-release capsules in the USA as a treatment of obesity, including weight loss and maintenance of weight loss, in patients who are obese or overweight with co-morbidities such as hypertension, type 2 diabetes, dyslipidemia or central adiposity.
But back in October US regulators issued the drugmaker with a series of concerns it had with the drug’s application, including within clinical, labelling, safety and drug scheduling areas.
On the clinical side, the FDA has requested a comprehensive assessment of topiramate's and Qnexa’s teratogenic potential, including a detailed plan and strategy to assess and deal with the potential risks in women of childbearing age. In addition, it has asked for evidence that the elevation in heart rate associated with phentermine/topiramate does not increase the risk for major cardiovascular side effects.
But the company is evidently confident of ultimately securing approval for the drug. “Submission of our briefing document and confirmation of our meeting with the FDA indicate the continued progress Vivus is making in seeking US approval of Qnexa for the treatment of obesity," said Leland Wilson, chief executive officer of Vivus. "We are confident in the data analyses we have compiled in the briefing document, and we look forward to our meeting with the FDA,” he added.
http://www.pharmatimes.com/Article/10-12-15/Vivus_replies_to_FDA_s_concerns_over_Qnexa.aspx 认领。 Vivus replies to FDA’s concerns over Qnexa
美国维佛斯制药公司答复了FDA关于减肥药奎尼克的疑虑
Vivus has responded to the US Food and Drug Administration’s complete response letter regarding its application to market Qnexa as a treatment for obesity and weight loss.
美国维佛斯制药公司逐一答复了美国食品及药物管理局（FDA）“关于申请减肥药奎尼克（Qnexa）上市销售治疗肥胖和减轻体重”的详细质询信。
The company has submitted a briefing document to agency addressing the various concerns it had with the New Drug Application, and also announced that it has been grated a meeting with the FDA’s Endocrine and Metabolic Division in the second half of January to discuss its proposed resubmission.
维佛斯制药公司向美国食品及药物管理局递交了简要申报资料,以就新药上市申请有关的各种考虑进行了阐述；并告之乐意参加，明年1月中旬，美国食品及药物管理局内分泌学和代谢部门的专家举行讨论其再提交的有关资料的会议。
Vivus is seeking to market Qnexa (phentermine/topiramate) controlled-release capsules in the USA as a treatment of obesity, including weight loss and maintenance of weight loss, in patients who are obese or overweight with co-morbidities such as hypertension, type 2 diabetes, dyslipidemia or central adiposity.
维佛斯制药公司一直在致力于促成奎尼克（芬特明/托吡酯）控释胶囊在美国上市销售治疗肥胖，包括减轻体重和维持减轻体重；目标人群为肥胖患者或者伴有例如高血压、2型糖尿病、血脂异常或向心性肥胖等病的超重者。
But back in October US regulators issued the drugmaker with a series of concerns it had with the drug’s application, including within clinical, labelling, safety and drug scheduling areas.
但是，今年10月后，美国食品及药物管理局监管机构发布了有关新药申请，包括临床试验研究、说明书标签、安全性和药物拟销售的地区等等一系列制药者法律法规文件。
On the clinical side, the FDA has requested a comprehensive assessment of topiramate's and Qnexa’s teratogenic potential, including a detailed plan and strategy to assess and deal with the potential risks in women of childbearing age. In addition, it has asked for evidence that the elevation in heart rate associated with phentermine/topiramate does not increase the risk for major cardiovascular side effects.
关于临床试验研究，美国食品及药物管理局要求维佛斯制药公司进行托吡酯.和奎尼克的致畸性潜在危害的全面评估，包括评估和处理对育龄妇女的潜在风险的详细的计划和策略。此外，FDA还要求维佛斯制药公司提供芬特明/托吡酯可以增加心率而不增加受试者主要心血管副作用的证据。
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作者:admin@医学,生命科学 2010-12-25 02:22
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