4月14日，勃林格殷格翰与礼来称，美国FDA接受了Empagliflozin和利格列汀复方药物片剂用于2型糖尿病的新药申请(NDA)。
如果获得FDA批准，该复方药物将成为首款将两种明显不同作用机制——一种钠葡萄糖协同转运蛋白-2 (SGLT2)抑制剂和一种二肽基肽酶4（DPP-4）抑制剂——药物组合一起的复方新药。SGLT2抑制剂通过阻止葡萄糖在肾内的重吸收使过多的葡萄糖通过尿排除。DPP-4抑制剂通过增加刺激胰腺产生更多胰岛素及刺激肝脏产生更少的葡萄糖而起作用。
“FDA接受Empagliflozin和利格列汀复方药物的新药申请可为为2型糖尿病患者带来新的治疗选择，通过DPP-4抑制剂与SGLT2抑制剂双重作用来降低血糖，”勃林格殷格翰代谢性临床药物开发及医疗事务副总裁、医学博士、哲学博士Christophe Arbet-Engels如是说道。“2型糖尿病成人患者通常使用一种以上的治疗药物来管理疾病，我们希望这两款药物组成的复方药物会帮助患者改善血糖控制。”
在提交新药申请之前，两家公司刚刚完成了一项3期临床试验，目的是在2型糖尿病成人患者中评价Empagliflozin/利格列汀复方药物与其单个药物组份相比的有效性与安全性。勃林格殷格翰与礼来的糖尿病联盟打算于今年底发布这项研究的数据。
利格列汀片在美国以Tradjenta为商品名上市，日服一次，每片5mg，结合饮食及锻炼用以改善2型糖尿病成人患者的血糖控制。利格列汀不应用于1型糖尿病患者，也不能用于糖尿病酮症酸中毒治疗。利格列汀尚未被研究用于有胰腺炎病史的患者。
RIDGEFIELD, Conn. and INDIANAPOLIS, April 14, 2014 /PRNewswire/ -- Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Company (Lilly; NYSE: LLY) today announced the U.S. Food and Drug Administration (FDA) accepted the filing of the New Drug Application (NDA) for the investigational combination tablet of empagliflozin and linagliptin for the treatment of adults with type 2 diabetes (T2D).
If granted approval by the FDA, this combination will bring together, for the first time into one tablet, the distinct mechanisms of action of a sodium glucose co-transporter-2 (SGLT2) inhibitor and a dipeptidyl peptidase-4 (DPP-4) inhibitor. SGLT2 inhibitors remove excess glucose through the urine by blocking glucose re-absorption in the kidney. DPP-4 inhibitors work by increasing hormones that stimulate the pancreas to produce more insulin and stimulate the liver to produce less glucose.
"The FDA acceptance of our filing for the combination tablet of empagliflozin and linagliptin brings us closer to providing patients with type 2 diabetes a potential treatment option that lowers blood sugar through the dual mechanism of action of a DPP-4 inhibitor and an SGLT2 inhibitor," said Christophe Arbet-Engels, MD, PhD, vice president, me-tabolic-clinical development and medical affairs, Boehringer Ingelheim Pharmaceuticals, Inc. "Adults living with type 2 diabetes often take more than one therapy to manage their condition, and we hope the combination of these two products will help them improve control of their blood sugar."
The filing follows the completion of a phase III clinical registration trial designed to eva1uate the efficacy and safety of the empagliflozin/linagliptin combination compared to the individual components in adults with T2D. The Boehringer Ingelheim and Lilly Diabetes alliance plans to present data from this study later this year.
Linagliptin, which is marketed as Tradjenta® (linagliptin) tablets in the U.S., is a once-daily, 5-mg tablet used along with diet and exercise to improve glycemic control in adults with T2D. TRADJENTA should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis. TRADJENTA has not been studied in patients with a history of pancreatitis.1
What are TRADJENTA tablets?
TRADJENTA is a prescri-ption medicine that is used along with diet and exercise to lower blood sugar in adults with type 2 diabetes.
TRADJENTA is not for people with type 1 diabetes or for people with diabetic ketoacidosis (increased ketones in the blood or urine).
If you have had inflammation of the pancreas (pancreatitis) in the past, it is not known if you have a higher chance of getting pancreatitis while you take TRADJENTA.
imp0rtant Safety Information
What is the most imp0rtant information I should know ab0ut TRADJENTA?
Serious side effects can happen to people taking TRADJENTA, including inflammation of the pancreas (pancreatitis), which may be severe and lead to death. Before you start taking TRADJENTA, tell your doctor if you have ever had pancreatitis, gallstones, a history of alcoholism, or high triglyceride levels.
Stop taking TRADJENTA and call your doctor right away if you have pain in your stomach area (abdomen) that is severe and will not go away. The pain may be felt going from your abdomen through to your back. The pain may happen with or without vomiting. These may be symptoms of pancreatitis.
Who should not take TRADJENTA?
Do not take TRADJENTA if you are allergic to linagliptin or any of the ingredients in TRADJENTA.
Symptoms of a serious allergic reaction to TRADJENTA may include rash, itching, flaking or peeling; raised red patches on your skin (hives); swelling of your face, lips, tongue and throat that may cause difficulty breathing or swallowing. If you have any symptoms of a serious allergic reaction, stop taking TRADJENTA and call your doctor right away.
What should I tell my doctor before using TRADJENTA?
Tell your doctor ab0ut all the medicines you take, including prescri-ption and non-prescri-ption medicines, vitamins, and herbal supplements. TRADJENTA may affect the way other medicines work, and other medicines may affect how TRADJENTA works.
Especially tell your doctor if you take
Other medicines that can lower your blood sugar, such as a sulfonylurea or insulin.
TRADJENTA may cause serious side effects, including low blood sugar (hypoglycemia). If you take TRADJENTA with another medicine that can cause low blood sugar, such as sulfonylurea or insulin, your risk of getting low blood sugar is higher. The dose of your sulfonylurea or insulin may need to be lowered while you take TRADJENTA.
Signs and symptoms of low blood sugar may include headache, drowsiness, weakness, dizziness, confusion, irritability, hunger, fast heartbeat, sweating, or feeling jittery.
rifampin (Rifadin®, Rimactane®, Rifater®, Rifamate®)^, an antibiotic that is used to treat tuberculosis.
Tell your doctor if you are pregnant or planning to become pregnant or are breastfeeding or plan to breastfeed.
What are the possible side effects of TRADJENTA?
The most common side effects of TRADJENTA include stuffy or runny nose, sore throat, cough and diarrhea.
You are encouraged to report negative side effects of prescri-ption drugs to the U.S. FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
For more safety information, please see Medication Guide and full Prescribing Information.
TJ CONS ISI 19JUNE2013
^The brands listed are trademarks of their respective owners and are not trademarks of Boehringer Ingelheim Pharmaceuticals, Inc. The makers of these brands are not affiliated with and do not endorse Boehringer Ingelheim Pharmaceuticals, Inc., or its products.
To learn more ab0ut TRADJENTA visit: www.TRADJENTA.com. For full Prescribing Information and Medication Guide visit: http://bidocs.boehringer-ingelheim.com/BIWebAccess/ViewServlet.ser?
docBase=renetnt&folderPath=/Prescribing+Information/PIs/Tradjenta/Tradjenta.pdf
Please report any unexpected effects or product problems to the Boehringer Ingelheim Drug Information Unit by calling 1-800-542-6257.
ab0ut Diabetes
Approximately 24.4 million Americans and an estimated 382 million people worldwide have type 1 or type 2 diabetes. Type 2 diabetes is the most common type, accounting for an estimated 85 to 95 percent of all diabetes cases. Diabetes is a chronic condition that occurs when the body either does not properly produce, or use, the hormone insulin.2
Boehringer Ingelheim and Eli Lilly and Company
In January 2011, Boehringer Ingelheim and Eli Lilly and Company announced an alliance in diabetes that centers on compounds representing several of the largest diabetes treatment classes. The alliance leverages the strengths of two of the world's leading pharmaceutical companies. By joining forces, the companies demonstrate commitment in the care of patients with diabetes and stand together to focus on patient needs. Find out more ab0ut the alliance at www.boehringer-ingelheim.com or www.lilly.com.
ab0ut Boehringer Ingelheim
Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the largest U.S. subsidiary of Boehringer Ingelheim Corporation (Ridgefield, CT) and a member of the Boehringer Ingelheim group of companies.
The Boehringer Ingelheim group is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 140 affiliates and more than 46,000 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel medications of high therapeutic value for human and veterinary medicine.
As a central element of its culture, Boehringer Ingelheim has a demonstrated commitment to corporate social responsibility. Involvement in social projects, caring for employees and their families, and providing equal opportunities for all employees form the foundation of the global operations. Mutual cooperation and respect, as well as environmental protection and sustainability are intrinsic factors in all of Boehringer Ingelheim's endeavors.
In 2012, Boehringer Ingelheim achieved net sales of ab0ut $19.1 billion (14.7 billion euro). R&D expenditure in the business area Prescri-ption Medicines corresponds to 22.5 percent of its net sales.
For more information please visit www.us.boehringer-ingelheim.com.
ab0ut Eli Lilly and Company
Lilly is a global healthcare leader that unites caring with discovery to make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. To learn more ab0ut Lilly, please visit us at www.lilly.com and http://newsroom.lilly.com/social-channels.
ab0ut Lilly Diabetes
Lilly has been a global leader in diabetes care since 1923, when we introduced the world's first commercial insulin. Today we are building upon this heritage by working to meet the diverse needs of people with diabetes and those who care for them. Through research and collaboration, a broad and growing product portfolio and a continued determination to provide real solutions—from medicines to support programs and more—we strive to make life better for all those affected by diabetes around the world. For more information, visit www.lillydiabetes.com.
This press release contains forward looking statements ab0ut the investigational fixed-dose combination of empagliflozin and linagliptin. Empagliflozin is an investigational SGLT2 inhibitor being studied for the treatment of type 2 diabetes, and linagliptin, a DPP-4 inhibitor, is approved for the treatment of type 2 diabetes along with diet and exercise. It reflects Lilly's current beliefs; however, as with any such undertaking, there are substantial risks and uncertainties in the process of drug development and commercialization. There is no guarantee that future study results and patient experience will be consistent with study findings to date, or that the investigational fixed-dose combination of empagliflozin and linagliptin will be commercially successful, or that it will receive regulatory approvals. For further discussion of these and other risks and uncertainties, please see Lilly's latest Forms 10-Q and 10-K filed with the U.S. Securities and Exchange Commission. Lilly undertakes no duty to updat forward-looking statements.
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