Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Company announced Tradjenta (linagliptin) tablets are now available by prescription in pharmacies across the United States including Walgreens, CVS, Rite Aid and many leading chain and independent pharmacies. The US Food and Drug Administration (FDA) approved Tradjenta on May 2, 2011 as a prescription medication used along with diet and exercise to lower blood sugar in adults with type 2 diabetes. Tradjenta should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis (increased ketones in the blood or urine). It has not been studied in combination with insulin.
“The rapid availability of Tradjenta for adults with type 2 diabetes following FDA approval is a testament to Boehringer Ingelheim and Lilly's joint commitment to improving patient care,” said Wa'el Hashad, vice president, cardiovascular and metabolic disorders, Boehringer Ingelheim Pharmaceuticals, Inc. “The health of patients is our first priority and we work diligently to ensure our medications are accessible for patients. With just one dose to remember for all patients, Tradjenta is an important new treatment option that could help the millions of Americans living with type 2 diabetes.”
Boehringer Ingelheim and Lilly are in active discussions with various insurance companies about formulary coverage and are seeking for Tradjenta to be reimbursed at a co-pay level similar to other preferred branded products. The wholesale acquisition price for Tradjenta is $ 6.77 per tablet.
A Savings Card Programme for Tradjenta is available for patients who qualify. As part of the program, most commercially insured eligible patients pay no more than $ 10 per month with a maximum savings of $ 150 per month. Eligible cash-paying patients without commercial prescription coverage receive up to $ 150 in savings per 30-day supply of Tradjenta. The Savings Card Programme is valid for up to 24 months and is now available in many doctors' offices and online. Patients are not eligible if prescriptions are paid in part or full by any state or federally funded programs.
In addition, the Boehringer Ingelheim Cares Foundation Patient Assistance Programmes make Boehringer Ingelheim medicines, including Tradjenta, available free of charge to patients who are without pharmaceutical insurance coverage, and who meet certain household income levels.
Tradjenta belongs to a class of prescription medications called Dipeptidyl Peptidase-4 (DPP-4) inhibitors and is the first member of its class to be approved at one dosage strength (5 mg, once daily). With Tradjenta, no dose adjustment is recommended for patients with kidney or liver impairment. It is a tablet that can be taken with or without food. Tradjenta lowers blood sugar in a glucose-dependent manner by increasing incretin levels, which increase insulin levels after meals and throughout the day.
Tradjenta can be used as monotherapy or in combination with other commonly prescribed medications for type 2 diabetes — metformin, sulfonylurea or pioglitazone — and demonstrated reductions in haemoglobin A1C (HbA1c or A1C) levels up to 0.7 percent (compared to placebo). A1C is measured in people with diabetes to provide an index of blood sugar control for the previous two to three months.
Tradjenta was approved based on a clinical trial programme that included approximately 4,000 adults with type 2 diabetes. Included in the program were placebo-controlled studies evaluating Tradjenta as monotherapy and in combination with some commonly prescribed medications for type 2 diabetes —metformin, sulfonylurea or pioglitazone. It showed statistically significant A1C reductions of up to 0.7 percent when used as monotherapy (compared to placebo). When used in combination with metformin, sulfonylurea, and metformin plus sulfonylurea, the addition of Tradjenta resulted in significant A1C reductions of 0.6, 0.5, and 0.6 percent respectively (compared to placebo). In the initial combination of Tradjenta plus pioglitazone, significant reductions in A1C of 0.5 percent were observed compared to placebo.
Adverse reactions reported in greater than or equal to five percent of patients treated with Tradjenta and more commonly than in patients treated with placebo included nasopharyngitis. Hypoglycaemia was more commonly reported in patients treated with the combination of Tradjenta and sulfonylurea compared with those treated with the combination of placebo and sulfonylurea. The incidence of hypoglycaemia was similar to placebo when Tradjenta was administered as monotherapy or in combination with metformin or pioglitazone. Pancreatitis was reported more often in patients randomized to Tradjenta (one per 538 person-years versus zero in 433 person-years for comparator).
Under the programme, most commercially insured eligible patients will pay no more than $ 10 per month with a maximum savings of $ 150 per month. Eligible cash-paying patients without commercial prescription coverage will receive up to $ 150 in savings per 30-day supply of Tradjenta. The activation deadline is May 31, 2012, and this offer is only valid for prescriptions filled during 24 consecutive months from the date of activation. Limit 1 card per patient.
Boehringer Ingelheim has been focused on improving the lives of patients. In keeping with the company commitment to do the most good for the most people, Boehringer Ingelheim works hard to ensure its medicines are accessible to everyone who needs them, including senior citizens and families on limited incomes. The Boehringer Ingelheim Cares Foundation Patient Assistance Programs (BI-PAP) make Boehringer Ingelheim medicines available free of charge to patients who are without pharmaceutical insurance coverage, and who meet certain household income levels.
Approximately 25.8 million Americans and an estimated 220 million people worldwide have type 1 and type 2 diabetes. Type 2 diabetes is the most common type, accounting for an estimated 90 to 95 percent of all diabetes cases. Diabetes is a chronic disease that occurs when the body either does not properly produce, or use, the hormone insulin.
In January 2011, Boehringer Ingelheim and Eli Lilly and Company announced an alliance in the field of diabetes that centres on four pipeline compounds representing several of the largest treatment classes. This alliance leverages the companies' strengths as two of the world's leading pharmaceutical companies, combining Boehringer Ingelheim's solid track record of research-driven innovation and Lilly's innovative research, experience, and pioneering history in diabetes. By joining forces, the companies demonstrate commitment in the care of patients with diabetes and stand together to focus on patient needs.
Boehringer Ingelheim Pharmaceuticals, Inc., committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine.
Lilly, a leading innovation-driven corporation, is developing a growing portfolio of pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations.