| 查看: 660 | 回复: 0 | ||
[资源]
糖尿病新靶点药物-SGLT-2抑制剂Dapagliflozin Rejected by F.D.A. Panel
|
|
AstraZeneca and Bristol-Myers Squibb Company today reported the outcome of the US Food and Drug Administration's (FDA) Endocrinologic and Metabolic Drugs Advisory Committee meeting on the New Drug Application for the investigational compound dapagliflozin. On the question: "Do the efficacy and safety data provide substantial evidence to support approval of dapagliflozin as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus?", the Advisory Committee voted 6 yes and 9 no. Bristol-Myers Squibb and AstraZeneca remain committed to the dapagliflozin clinical development programme and will continue to work closely with the FDA to support the review of this investigational compound. Dapagliflozin is under joint development by Bristol-Myers Squibb and AstraZeneca. Dapagliflozin is being investigated as monotherapy in addition to diet and exercise, and in combination with other anti-diabetic agents in addition to diet and exercise, to evaluate its effect on blood sugar levels (or HbA1c) in adults with type 2 diabetes. Dapagliflozin, an inhibitor of SGLT2, a target in the kidney, would potentially be the first in a new class of insulin-independent, oral type 2 diabetes agents. The FDA Endocrinologic and Metabolic Drugs Advisory Committee based its voting on a review of data from the comprehensive dapagliflozin global clinical development programme included as part of the FDA New Drug Application submission. This submission included data of up to two years in duration and involved approximately 6,000 individuals in 40 clinical studies. The trials were designed to evaluate the safety, tolerability and efficacy (as measured by HbA1c) of dapagliflozin in the approximately 4,200 patients who received dapagliflozin and were at various stages of the continuum of type 2 diabetes. In accordance with FDA guidelines, the New Drug Application also included data assessing the cardiovascular safety of dapagliflozin in adults with type 2 diabetes. The FDA is not bound by the Advisory Committee's recommendation but takes its advice into consideration when reviewing New Drug Applications. The Prescription Drug User Fee Act (PDUFA) goal date for dapagliflozin is 28 October 2011. NOTES TO EDITORS About Type 2 Diabetes In 2010, diabetes was estimated to affect nearly 300 million people aged 20 - 79 worldwide. Because of the aging population and the growing trend of obesity, the prevalence of diabetes is projected to reach nearly 440 million by 2030. Type 2 diabetes accounts for approximately 90 - 95% of all cases of diagnosed diabetes in adults. Type 2 diabetes is a chronic, progressive disease characterised by insulin resistance and/or dysfunction of beta cells in the pancreas, which decreases insulin sensitivity and secretion, leading to elevated glucose levels. Over time, this sustained hyperglycemia contributes to worsening insulin resistance and further beta cell dysfunction. To date, treatments for type 2 diabetes have focused primarily on insulin-dependent mechanisms. An approach that acts independently of insulin could provide an additional option for adults with type 2 diabetes. Significant unmet needs exist as nearly half of treated patients remain uncontrolled on their current glucose-lowering regimen. Many patients with type 2 diabetes have additional co-morbidities (such as obesity) which may complicate glycemic control. About SGLT2 Inhibition The kidney plays an important role in glucose balance, normally filtering ~180g of glucose each day, with virtually all glucose being reabsorbed back into circulation. SGLT2 is the major sodium-glucose cotransporter in the kidney and is an insulin-independent pathway for the reabsorption of glucose back into the blood. 、 |
回复此楼» 猜你喜欢
全球性的医药交易平台
已经有1人回复
-
316求调剂
已经有0人回复
-
药理学论文润色/翻译怎么收费?
已经有72人回复
-
求购时间长一些的硝酸钍
已经有0人回复
-
这个自发加氧反应的机理是什么？
已经有7人回复
找到一些相关的精华帖子，希望有用哦~
【课件】天然药物化学（华中科技大学）
已经有275人回复
- 博士点基金的到账时间
已经有6人回复
- 要不要转2+3博士 药物化学专业
已经有15人回复
- 有机合成，药物化学，文章影响因子数
已经有15人回复
- 【习题资源】药物化学习题
已经有54人回复
- 分子靶向抗肿瘤药物研究进展
已经有188人回复
- 【纳米医学】夏幼南最新一篇关于靶向药物的报道
已经有119人回复
点击这里搜索更多相关资源科研从小木虫开始，人人为我，我为人人
50