Diabetes drug gets thumbs-up from FDA

The diabetes alliance between Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Company has borne fruit.

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RIDGEFIELD, Conn. and INDIANAPOLIS—The diabetes alliancebetween Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Companyhas borne fruit. The two companies announced that the U.S. Food and DrugAdministration (FDA) has approved TRADJENTA tablets, a prescription medicationthat, along with diet and exercise, is used to lower blood sugar levels inadults with Type 2 diabetes. Boehringer Ingelheim and Eli Lilly formed aworldwide diabetes alliance in January 2011, and the FDA approval of TRADJENTAmarks the alliance's first regulatory milestone.
"Our alliance with Boehringer Ingelheim represents one ofthe most robust diabetes pipelines in the pharmaceutical industry," saysEnrique Conterno, president of Lilly Diabetes. "TRADJENTA is the firstregulatory approval of what we hope will be many new treatment options thisalliance brings to the millions of Americans living with type 2 diabetes."
The diabetes drug is part of a class of medications calleddipeptidyl peptidase-4 (DPP-4) inhibitors, and the first of its class to beapproved at a single dosage strength. It works to lower blood sugar in aglucose-dependent manner by increasing incretin levels, which are responsiblefor increasing insulin levels after eating and during the day. TRADJENTA istaken once daily (5 mg), and can be used alone or in combination with commonlyprescribed medications for type 2 diabetes, such as metformin, sulfonylurea orpioglitazone, though it has not been studied in combination with insulin.
TRADJENTA was tested in a clinical trial of approximately4,000 adults with type 2 diabetes in placebo-controlled studies as amonotherapy and also in combination with medications commonly prescribed fortype 2 diabetes. It showed significant A1C reductions of up to 0.7 percent whenused alone, compared to placebo, and when used in tandem with metformin,sulfonylurea and metformin plus sulfonylurea, it showed A1C reductions of 0.6,0.5 and 0.6 percent respectively, compared to placebo. When TRADJENTA wascombined with pioglitazone, reductions in A1C of 0.5 percent were seen whencompared to placebo. A1C is measured in diabetes sufferers in order toascertain an index of blood sugar control for the previous two to three months.
"Many people with type 2 diabetes are not able to controltheir blood sugar with diet and exercise alone and may also require one or moremedications," says John Gerich M.D., professor of medicine at the University ofRochester School of Medicine. "The FDA approval of TRADJENTA is excitingbecause there is only one dose to remember for all patients, regardless ofkidney or liver impairment. With TRADJENTA, physicians will have another optionfor managing type 2 diabetes, a potentially devastating condition."
Those who took TRADJENTA alone, or in combination withmetformin, sulfonylurea or pioglitazone, saw significant reductions in bothfasting plasma glucose (FPG) compared to those taking the placebo, andreductions in two-hour post-prandial glucose (PPG) levels as well, when takenalone or in combination with metformin. FPG is used to gauge glucose levels ina fasting state, often first thing in the morning, and PPG determines glucoselevels after meals. Patients who took TRADJENTA saw a significant mean decreasein baseline body weight, compared to the significant weight gain seen inpatients who were treated with sulfonylurea. Adverse reactions to the drugincluded nasopharyngitis, hypoglycemia and pancreatitis.
Approximately 220 million people worldwide, 25.8 million ofthose being Americans, have type 1 and type 2 diabetes, with type being themost common and making up about 95 percent of all cases, according to the Centers for Disease Control and Prevention and the World Health Organization. Albert Ros, presidentand CEO of Boehringer Ingelheim, notes that "type 2 diabetes is increasing atan alarming rate."
"We are proud to offer a new treatment option that couldpotentially help the millions of people with type 2 diabetes whose blood sugaris uncontrolled," says Ros. "When we introduce a new medicine to themarketplace, our goal is to improve patient care, and we are hopeful thatTRADJENTA will help do that."

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