FDA Approves Tradjenta (linagliptin) for Treatment of Type 2 Diabetes

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Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Company (NYSE: LLY) today announced that the U.S. Food and Drug Administration (FDA) has approved Tradjenta (linagliptin) tablets, a prescription medication used along with diet and exercise to lower blood sugar in adults with type 2 diabetes. 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 hemoglobin 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 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.

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. TRADJENTA 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.

"Many people with type 2 diabetes are not able to control their blood sugar with diet and exercise alone and may also require one or more medications," said John Gerich M.D., professor of medicine, University of Rochester School of Medicine. "The FDA approval of TRADJENTA is exciting because there is only one dose to remember for all patients, regardless of kidney or liver impairment. With TRADJENTA, physicians will have another option for managing type 2 diabetes, a potentially devastating condition."

TRADJENTA 5 mg once daily was approved based on a clinical trial program which 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 the commonly prescribed medications for type 2 diabetes "metformin, sulfonylurea or pioglitazone. TRADJENTA 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.

Treatment with TRADJENTA also produced significant reductions in fasting plasma glucose (FPG) compared to placebo, when used as monotherapy and in combination with metformin, sulfonylurea or pioglitazone. Treatment with TRADJENTA produced significant reductions in two-hour post-prandial glucose (PPG) levels compared with placebo as monotherapy and when used in combination with metformin. FPG is used to determine glucose levels in a fasting state (usually upon wakening in the morning), and PPG is used to determine glucose levels after meals (usually two hours after eating).

In controlled studies, change from baseline in body weight did not differ significantly between groups when TRADJENTA was administered as monotherapy, in combination with metformin or in combination with metformin plus sulfonylurea. Patients treated with TRADJENTA exhibited a significant mean decrease from baseline body weight compared to a significant weight gain in patients administered sulfonylurea (-1.1 kg vs. +1.4 kg. p<0.0001). Patient weight increased in both the TRADJENTA plus pioglitazone and placebo plus pioglitazone groups during the study with an adjusted mean change from baseline of 2.3 kg and 1.2 kg, respectively (p=0.0141).

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. Hypoglycemia 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 hypoglycemia 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).

"Type 2 diabetes is increasing at an alarming rate and we are proud to offer a new treatment option that could potentially help the millions of people with type 2 diabetes whose blood sugar is uncontrolled," said Albert Ros, president and CEO, Boehringer Ingelheim Pharmaceuticals, Inc. "When we introduce a new medicine to the marketplace, our goal is to improve patient care and we are hopeful that TRADJENTA will help do that."

The FDA approval of TRADJENTA marks the first regulatory milestone since the formation of the Boehringer Ingelheim and Eli Lilly and Company worldwide diabetes alliance in January 2011. The alliance leverages the collective scientific expertise and business capabilities of two leading research-driven pharmaceutical companies to address patient needs arising from the growing global diabetes epidemic.

"Our alliance with Boehringer Ingelheim represents one of the most robust diabetes pipelines in the pharmaceutical industry," said Enrique Conterno, president of Lilly Diabetes. "TRADJENTA is the first regulatory approval of what we hope will be many new treatment options this alliance brings to the millions of Americans living with type 2 diabetes."

The overall clinical development program for TRADJENTA consists of 30 studies completed, underway or planned. TRADJENTA is currently under regulatory review in the EU and Japan.
About Diabetes

Approximately 25.8 million Americans1 and an estimated 220 million people worldwide2 have type 1 and type 2 diabetes. Type 2 diabetes is the most common type, accounting for an estimated 95 percent of all diabetes cases.1 Diabetes is a chronic disease that occurs when the body either does not properly produce, or use, the hormone insulin.3

What are TRADJENTA tablets

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).

It is not known if TRADJENTA is safe and effective when used with insulin.

Important Safety Information

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 are rash, raised red patches on your skin (hives), swelling of your face, lips, 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 taking TRADJENTA

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you take other medicines that can lower your blood sugar, such as a sulfonylurea or insulin. If you take TRADJENTA with another medicine that can cause low blood sugar (hypoglycemia), such as a sulfonylurea or insulin, your risk of getting low blood sugar is higher. The dose of your sulfonylurea medicine 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 heart beat, sweating, or feeling jittery.

Also tell your doctor if you take rifampin (Rifadin®, Rimactane®, Rifater®, Rifamate®), an antibiotic that is used to treat tuberculosis.

TRADJENTA may affect the way other medicines work, and other medicines may affect how TRADJENTA works.

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 and sore throat.

You are encouraged to report negative side effects of prescription drugs to the FDA.

For more safety information, please see Patient Information and full Prescribing Information.