Ridgefield, CT and Indianapolis, IN /PRNewswire/ - The U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for the investigational fixed-dose combination tablet of empagliflozin, linagliptin and metformin extended release (XR) for the treatment of adults with type 2 diabetes, Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) announced.
"Millions of adults with type 2 diabetes take multiple medicines to control their condition," said Mohamed Eid, M.D., M.P.H., M.H.A., vice president, Clinical Development & Medical Affairs, Boehringer Ingelheim Pharmaceuticals, Inc. "If approved by the FDA, the combination tablet would be one of the first single-pill options with three complementary mechanisms of action to help manage blood glucose in adults with type 2 diabetes who could benefit from having empagliflozin and linagliptin as part of their treatment regimen, in addition to metformin."
Empagliflozin, marketed as Jardiance® in the U.S., is a sodium glucose co-transporter-2 (SGLT-2) inhibitor, which removes excess glucose through the urine by blocking glucose re-absorption in the kidney. Jardiance is a once-daily tablet used along with diet and exercise to lower blood sugar in adults with type 2 diabetes and is indicated to reduce the risk of cardiovascular death in adults with type 2 diabetes and known cardiovascular disease. Jardiance is not for people with type 1 diabetes or for people with diabetic ketoacidosis (increased ketones in the blood or urine).
Linagliptin, marketed as Tradjenta® tablets in the U.S., is a dipeptidyl peptidase-4 (DPP-4) inhibitor, which controls glucose by increasing hormones that stimulate the pancreas to secrete insulin and stimulate the liver to produce less glucose. Tradjenta is a once-daily, 5 mg tablet used along with diet and exercise to lower blood sugar in adults with type 2 diabetes. The long-term cardiovascular safety profile of Tradjenta has been studied in two separate cardiovascular outcomes trials of adults with type 2 diabetes and increased cardiovascular risk. Tradjenta should not be used in people with type 1 diabetes or for the treatment of diabetic ketoacidosis. Tradjenta has not been studied in people with a history of pancreatitis.
Metformin, which decreases the production of glucose in the liver and its absorption in the intestine and improves the body's sensitivity to insulin and ability to utilize glucose, is the most commonly prescribed initial treatment for type 2 diabetes.
"Boehringer Ingelheim and Lilly continue to provide a range of treatment options to help improve overall care and outcomes for adults with type 2 diabetes," said Sherry Martin, M.D., vice president, Medical Affairs, Lilly. "We look forward to working with the FDA to make this combination tablet of empagliflozin, linagliptin and metformin XR available in hopes that it may help adults with type 2 diabetes better manage their condition with their healthcare providers."
The NDA is based on two randomized open-label trials that assessed the bioequivalence of empagliflozin, linagliptin and metformin XR investigational fixed-dose combination tablets and their individual components in healthy adults. Boehringer Ingelheim and Lilly plan to present results from the trials at a medical congress later this year.
Approximately 30 million Americans and an estimated 425 million people worldwide have diabetes, and nearly 24% of Americans with diabetes—or more than 7 million people—are undiagnosed. In the U.S., approximately 12% of those aged 18 and older have diabetes. Type 2 diabetes is the most common type, accounting for an estimated 90 to 95% of all diagnosed adult diabetes cases in the U.S. Diabetes is a chronic condition that occurs when the body does not properly produce or use the hormone insulin.
What is JARDIANCE? (www.jardiance.com)
JARDIANCE is a prescription medicine used along with diet and exercise to lower blood sugar in adults with type 2 diabetes.
JARDIANCE is also used to reduce the risk of cardiovascular death in adults with type 2 diabetes who have known cardiovascular disease.
JARDIANCE is not for people with type 1 diabetes or for people with diabetic ketoacidosis (increased ketones in the blood or urine).
IMPORTANT SAFETY INFORMATION
Do not take JARDIANCE if you are allergic to empagliflozin or any of the ingredients in JARDIANCE.
Do not take JARDIANCE if you have severe kidney problems or are on dialysis.
JARDIANCE can cause serious side effects, including:
The most common side effects of JARDIANCE include urinary tract infections and yeast infections in females.
These are not all the possible side effects of JARDIANCE. For more information, ask your doctor or pharmacist.
Before taking JARDIANCE, tell your doctor if you:
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your doctor if you take water pills (diuretics) or medicines that can lower your blood sugar, such as insulin.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visitwww.fda.gov/medwatch or call 1-800-FDA-1088.
For more information, please see Prescribing Information and Medication Guide.
What is TRADJENTA?
TRADJENTA is a prescription 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.
IMPORTANT SAFETY INFORMATION
What is the most important information I should know about 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.
Heart failure. Heart failure means your heart does not pump blood well enough. Before you start taking TRADJENTA, tell your doctor if you have ever had heart failure or have problems with your kidneys. Contact your doctor right away if you have any of the following symptoms: increasing shortness of breath or trouble breathing, especially when you lie down; swelling or fluid retention, especially in the feet, ankles, or legs; an unusually fast increase in weight or unusual tiredness. These may be symptoms of heart failure.
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 of these symptoms, stop taking TRADJENTA and call your doctor or go to the emergency room right away.
What should I tell my doctor before using TRADJENTA?
Tell your doctor about all your medical conditions, including if you have or have had inflammation of your pancreas (pancreatitis). Tell your doctor about all the medicines you take, including prescription and non-prescription 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
*These trademarks are owned by third parties not affiliated with TRADJENTA.
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?
TRADJENTA may cause serious side effects, including
The most common side effects of TRADJENTA include stuffy or runny nose, sore throat, cough, and diarrhea.
These are not all the possible side effects of TRADJENTA. For more information, ask your doctor or pharmacist. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
For more information, please see Prescribing Information and Medication Guide.
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. This 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 about the alliance at www.boehringer-ingelheim.com or www.lilly.com.
About Boehringer Ingelheim Pharmaceuticals, Inc.
Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, Conn., is the largest U.S. subsidiary of Boehringer Ingelheim Corporation.
Boehringer Ingelheim is one of the world's top 20 pharmaceutical companies. Headquartered in Ingelheim, Germany, the company operates globally with approximately 50,000 employees. Since its founding in 1885, the company has remained family-owned, and today our goal is to improve the lives of humans and animals through its three business areas: human pharmaceuticals, animal health and biopharmaceutical contract manufacturing.
Boehringer Ingelheim concentrates on developing innovative therapies that can improve and extend patients' lives. As a research-driven pharmaceutical company, it plans in generations for long-term success. Its research efforts are focused on diseases with high, unmet medical need. In animal health, the company stands for advanced prevention.
In 2018, Boehringer Ingelheim achieved net sales of around $20.7 billion (17.5 billion euros). R&D expenditure of almost $3.7 billion (3.2 billion euros) corresponded to 18.1 per cent of net sales.
Boehringer Ingelheim is committed to improving lives and strengthening our communities. Please visit www.boehringer-ingelheim.us/csr to learn more about Corporate Social Responsibility initiatives.
For more information, please visit www.boehringer-ingelheim.us, or follow us on Twitter @BoehringerUS.
About 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 wide range of therapies 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.
About 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 about Lilly, please visit us at www.lilly.com and newsroom.lilly.com/social-channels.
This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about an investigational fixed-dose combination of empagliflozin, linagliptin and metformin XR and reflects Lilly's current beliefs. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of drug development and commercialization. Among other things, there can be no guarantee that future study results will be consistent with the results to date or that the investigational fixed-dose combination of empagliflozin, linagliptin and metformin XR will receive regulatory approval. For a further discussion of these and other risks and uncertainties that could cause actual results to differ from Lilly's expectations, please see Lilly's most recent Forms 10-K and 10-Q filed with the U.S. Securities and Exchange Commission. Lilly undertakes no duty to update forward-looking statements.
Jardiance® and Tradjenta® are registered trademarks of Boehringer Ingelheim.
SOURCE: Eli Lilly and Company