勃林格-礼来糖尿病联盟8月26日宣布，在美国推出糖尿病新药Jardiance（empagliflozin），该药于今年8月1日获FDA批准，是该联盟在美国获批的第3个糖尿病产品。Jardiance的上市，对礼来而言尤其重要，该公司目前正面临着重磅产品的专利到期，正指望在短期内推出新产品以恢复增长。
此前，FDA因勃林格生产工厂问题拒绝批准Jardiance，导致Jardiance上市推迟了5个月之久，给礼来带来了不小的麻烦。
同时，Jardiance仍代表着礼来同其他制药公司SGLT-2抑制剂类药物抗衡的最佳人选，如强生的Invokana、阿斯利康和百时美施贵宝的Farxiga（dapagliflozin）。Invokana于2013年11月获FDA批准，Farxiga则在经历长期审查推迟后也最终于2014年1月获FDA批准。
Jardiance属于钠-葡萄糖协同转运蛋白-2（SGLT-2）抑制剂类药物。新兴的SGLT-2抑制剂类药物，已被证实能够阻断肾脏中葡萄糖的再吸收作用，将过多的葡萄糖排泄到体外，从而达到降低血糖水平的效果，而且该降糖效果不依赖于β细胞功能和胰岛素抵抗。
Jardiance获批剂量包括10mg和25mg片剂，每日一次，可单独用药也可与其他降糖药联合用药，包括胰岛素和二甲双胍。Jardiance的获批，是基于一项涵括超过10个跨国III期试验的大型临床项目的数据，涉及超过1.3万例2型糖尿病患者。该项目数据表明，Jardiance 10mg和25mg剂量作为单药疗法或与广泛的背景疗法（包括二甲双胍，磺酰脲，胰岛素，pioglitazone等）联合用药，均显著降低了患者的糖化血红蛋白（HA1c）水平，同时也显著降低了体重、血压。
英文原文：New type 2 diabetes treatment Jardiance® (empagliflozin) tablets for adults now available in U.S. pharmacies
New JARDIANCE Simple Savings program currently offered in doctors' offices and online
RIDGEFIELD, Conn. and INDIANAPOLIS, Aug. 26, 2014 /PRNewswire/ -- Jardiance® (empagliflozin) tablets are now available by prescription in pharmacies across the United States, including Walgreens, Rite Aid, Kroger and many other leading chain and independent retailers, according to Boehringer Ingelheim Pharmaceuticals, Inc. (BIPI) and Eli Lilly and Company (NYSE: LLY). The U.S. Food and Drug Administration (FDA) approved JARDIANCE on August 1, 2014 as an adjunct to diet and exercise to improve glycemic control, or blood glucose levels, in adults with type 2 diabetes (T2D). JARDIANCE is not for people with type 1 diabetes or for people with diabetic ketoacidosis (increased ketones in the blood or urine).
"As a testament to the joint commitment by Boehringer Ingelheim and Lilly to improve care for people with diabetes, our alliance is proud to make JARDIANCE available so quickly following its approval by the FDA," said Kathleen Dowd, senior vice president, marketing, Boehringer Ingelheim Pharmaceuticals, Inc. "We believe JARDIANCE is an exciting new treatment option with the potential to help many of the millions of adults with type 2 diabetes who have difficulty controlling their blood sugar levels."
JARDIANCE, a once-daily, 10 mg or 25 mg tablet, is a sodium glucose co-transporter-2 (SGLT2) inhibitor. JARDIANCE works by blocking the reabsorption of glucose in the kidney, increasing glucose excretion and lowering blood glucose levels in adults with type 2 diabetes who have elevated blood glucose levels.
Patients should not take JARDIANCE if they have severe kidney problems or are on dialysis, or if they are allergic to empagliflozin or any ingredient in JARDIANCE. JARDIANCE can cause some people to have dehydration (the loss of body water and salt), which may lead to a dro in blood pressure, and may cause patients to feel dizzy or faint.
The JARDIANCE Simple Savings co-pay support program is available online and in many doctors' offices for patients who qualify. For terms and conditions and any questions regarding eligibility or benefits, visit JARDIANCEsavings.com or call 1-866-279-8990.
The FDA approval of JARDIANCE was based on results from a large clinical program comprised of more than 10 multinational clinical trials and more than 13,000 adults with T2D. Phase III studies showed JARDIANCE significantly reduced hemoglobin A1C (a measure of average blood glucose over the past two to three months) after 24 weeks as a stand-alone treatment or in combination with a range of background treatments, including metformin, sulfonylureas, insulin and pioglitazone. Although JARDIANCE is not approved for lowering weight or blood pressure, modest reductions in both weight and systolic blood pressure were observed in clinical trials.
The most common adverse reactions associated with JARDIANCE were urinary tract infections and vaginal yeast infections. Hypoglycemia was more commonly reported in patients treated with the combination of JARDIANCE and sulfonylurea or insulin.
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