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Galvus New drug application for Galvus, an innovative oral therapy for people with type 2 diabetes, accepted for review by FDA Clinical studies show significant blood sugar reductions (HbA1c) sustained for one year EAST HANOVER, N.J., March 30, 2006 -- Novartis announced today that the new drug application (NDA) for Galvus* (vildagliptin, formerly LAF237) was accepted for standard review by the U.S. Food and Drug Administration (FDA). If approved, Galvus will provide a new, once-daily oral treatment option for people with type 2 diabetes. Submission for approval in Europe is on track to be completed later in 2006. Galvus, a DPP-4 inhibitor, works through a novel mechanism of action targeting the pancreatic islet dysfunction that causes high blood sugar levels in people with type 2 diabetes. Galvus affects both pancreatic alpha and beta cells, leading to a reduction in sugar production from the liver together with an increase in production of insulin needed to keep blood sugar under control. "The prevalence of diabetes is increasing and more than half of the people who are currently taking diabetes medications are still not reaching their blood sugar goals," said James Shannon, MD, Head of Development at Novartis Pharma AG. "Galvus may represent an exciting new option for the treatment of type 2 diabetes with the potential of helping patients reach and maintain their treatment goals with good tolerability." The submission includes data from clinical trials involving more than 4,300 patients worldwide evaluating the use of Galvus as monotherapy and also in combination with commonly prescribed anti-diabetic agents. Galvus is suitable for once-daily dosing. Overall, Galvus has shown clinically significant HbA1c reductions out to one year of treatment, with good overall tolerability and without causing weight gain. The most common side effects were cold-like symptoms, headache and dizziness. "Most of the treatments that we use today focus primarily on stimulating insulin secretion or lowering resistance," said Vivian Fonseca, MD, Professor of Medicine, Chief of Endocrinology and Metabolism, Tulane University Health Sciences Center, New Orleans, Louisiana. "The positive clinical results we've seen to date with Galvus underscore the importance and promise of addressing the dysfunction of both the pancreatic beta- and alpha-cells." About Galvus In clinical studies, Galvus has demonstrated significant reductions in blood sugar for one year. Galvus is suitable for once-daily dosing and has been evaluated both as monotherapy and in combination with other anti-diabetes agents. Galvus was not associated with overall weight gain, a key benefit for people with diabetes who struggle to keep their weight under control. The overall incidence of side effects with Galvus including hypoglycemia (excessively low blood sugar) and edema (fluid retention) was similar to placebo. Galvus lowers blood sugar by targeting islet dysfunction, i.e., it improves the ability of the islet's alpha- and beta-cells to appropriately sense and respond to sugar in the blood. About Diabetes Diabetes currently affects about 195 million people worldwide and is estimated to grow to more than 330 million by 2025, according to the International Diabetes Federation1. The U.S. Centers for Disease Control estimates that about 20 million Americans have diabetes. Type 2 diabetes is a progressive disease where control of blood sugar deteriorates over time. It is the sixth leading cause of death in the U.S. and a major contributor to heart disease, stroke, blindness, kidney disease and vascular or neurological problems that can result in amputation. Islet dysfunction and the body's resistance to insulin both contribute to diabetes. Specifically, islet dysfunction can lead to excess sugar production (via glucagon from the alpha-cells) and reduced insulin production (from the beta-cells). Even among people receiving diabetes care, controlling blood sugar levels is difficult. More than half of those currently taking medication to manage their diabetes are still not reaching their blood sugar goals, according to data from the National Health and Nutrition Examination Survey (NHANES)2. |
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最近在美国圣地亚哥举行了美国糖尿病学会年会，会上新一代口服糖尿病治疗药物dpp（二肽基肽酶）-iv抑制剂受到大会的注目，它属于非胰岛素治疗药物。这方面的专家lund大学bo ahren教授称它是恢复胰岛素细胞功能的“圣杯”。 分析家认为，这类药物一旦获得批准，将得到广泛的应用，因为，很多治疗糖尿病的药物都有体重增加和水肿不良反应，而dpp-iv抑制剂没有这种不良反应。二肽基肽酶能够断裂类胰增血糖素-肽-1（glp-1），所以抑制该酶后可以导致glp-1浓度提高。它是一种肠促胰岛素激素，在食后分泌，并促使胰脏倍他细胞产生胰岛素。它也可以抑制胰增血糖素的生成，从而增加glp-1浓度，恢复失去的胰岛素生成，降低胰 增血糖素浓度。 胰增血糖素指标是鉴别糖尿病的一个特性指标。dpp-iv抑制剂的作用很像已经获得批准的另一类新的糖尿病治疗药物肠促胰岛素类似物。第一个获得批准的肠促胰岛素类似物是礼来制药公司和amylin制药公司合作开发的byetta（合成肠促胰岛素类似物exenatide），是在2005年4月份批准上市的。天然glp-1只能注射使用，而且半衰期特别短。ddp-1抑制剂可以避免这些缺点，因为它是提高内源性的激素浓度，而不是通过合成方法，后者是外源性合成肠促胰岛素类似物。目前在研究前沿的ddp-1抑制剂化合物有诺华制药公司的vildagliptin和美国默克制药公司的sitagliptin。二者都在争取及早上市，估计诺华制药公司将在2006年下半年向fda递交申请，而默克制药公司将在2007年前递交申请，其实是在竞争首先上市，占领市场。 美国伯恩斯坦研究公司预测这二个化合物的销售可以达到15亿美元，ii期临床试验结果都比较积极，专家认为即使这类化合物的效果不如其他糖尿病治疗药物，但是，从安全性考虑。仍然会得到广泛的使用。美林咨询公司对这类化合物也抱乐观态度，认为sitagliptin到2009年的销售可以达到10亿美元，美林认为它的主要特性是高选择性和效果，作用持续，明显减少hba1c，没有体重增加和水肿不良反应。除了上述在iii期临床试验阶段的化合物外，其他同类产品还有百事美施贵宝公司的saxagliptin，probiodrug制药公司的p93/01（受让自默克制药公司和osi制药公司），都在ii期临床试验阶段。在i期临床试验阶段的有syrrx公司的syr-619，日本田边制药公司的ta-6666（受让自葛兰素史克制药公司）。瑞士罗氏制药公司和诺华诺德制药公司的化合物都还处于临床前试验阶段。 分析家认为这类化合物的销售在全球可以达到31亿美元。ii期临床试验结果：在全国糖尿病大会上，诺华制药公司和默克制药公司都报告了他们实验药物的ii期临床试验结果。默克制药公司做了sitagliptin（mk-0431）的3个降低血糖的临床试验，其中包括12周短期剂量试验、与二甲双胍复方药物试验，共计有1000位以上病人参加了试验。在剂量试验中，有552位ii型糖尿病病人参加，随机使用剂量为：每日25mg，50mg，100mg；每日二次50mg以及安慰剂。病人为轻度和中度高血糖，平均hba1c基础数据为7.7–7.8%。12周用药后，100mg组与安慰剂组比较，平均降低hba1c为0.6%。而基础hba1c为8.5–10.0%的病人使用100mgsitagliptin的降低hba1c效果达到1.1%。试验结果表明sitagliptin的耐受性很好，没有体重增加不良反应。另一个剂量试验有743病人参加，分别随机使用每日二次5mg，12.5mg，50mg剂量的sitagliptin，磺基脲化合物格列吡嗪5mg到20mg递加，或者安慰剂。病人也是轻度到中度糖尿病病人，基础hba1c为7.8–7.9%。结果在一日二次50mg试验组，和安慰剂组比较，hba1c平均下降0.77%，而格列吡嗪组平均下降1%。 不良反应方面，和安慰剂组比较，sitagliptin试验组没有明显体重增加；格列吡嗪组体重增加1.1kg；低血糖不良反应几率：sitagliptin试验组为4%，格列吡嗪试验组为17%，安慰剂组为2%。sitagliptin加二甲双胍复方和二甲双胍对照试验证明，复方效果比单方好，4周试验，平均为血糖浓度125mg/dl对158mg/dl。sitagliptin的作用达到下降33mg/dl。诺华制药公司vildagliptin的ii期临床试验用107位病人，历时52周，使用vildagliptin加二甲双胍，二甲双胍以及安慰剂进行对照试验。结果，复方试验组最好。试验结果表明该化合物可以改善倍他细胞功能。 |
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crack007
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4楼2006-05-15 02:07:23
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6楼2006-05-15 21:47:43
