Boehringer Ingelheim and Eli Lilly & Co. (LLY) said Friday that a panel of the European Medicines Agency has favored an expanded European approval of diabetes drug Trajenta (linagliptin) as add-on therapy to insulin in adults with Type 2 Diabetes.
Linagliptin is a prescription drug that is used along with diet and exercise to lower blood glucose in adults with Type 2 Diabetes. The drug is marketed as Trajenta across Europe and Canada, as Tradjenta in the US, and Trazenta in Japan, as well as in additional markets.
The European panel, known as the Committee for Medicinal Products for Human Use, has favored approval of linagliptin in combination with insulin with or without metformin, when this regimen alone with diet and exercise does not provide adequate glycemic control.
The CHMP's Positive Opinion is based on data from trials, which showed that adding linagliptin to insulin produced better glucose control than insulin alone, without an additional risk of hypoglycemia.
Linagliptin is an inhibitor of the enzyme DPP-4. Linagliptin glucose-dependently increases insulin secretion and lowers glucagon secretion thus resulting in an overall improvement in the glucose homoeostasis.
An estimated 366 million people worldwide have diabetes. Type 2 Diabetes is the most common type, accounting for an estimated 90% of all diabetes cases. Diabetes is a chronic condition that occurs when the body either does not properly produce, or use, the hormone insulin.
Shares of Eli Lilly are trading at $47.58, up 1.19%, on a volume of 3.8 million shares on the NYSE.
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