The US Food and Drug Administration (FDA) has granted marketing approval to a type 2 diabetes drug developed through a partnership between Lilly and Boehringer Ingelheim.
Approval of the drug, Tradjenta (linagliptin), is the first regulatory milestone in the companies' worldwide diabetes alliance since the partnership was formed in January of this year.
Tradjenta is indicated to lower blood sugar in adults when used in conjunction with a diet and exercise programme. The drug can be used as monotherapy or in combination with other commonly prescribed diabetes medications.
The therapy increases the level of hormones that stimulate the release of insulin after a meal by blocking the enzyme dipeptidyl peptidase-4 (DPP-4). It is the first of the DPP-4 inhibitors to be approved at one dosage strength (5 mg, once daily), with no dose adjustment necessary in patients with kidney or liver impairment.
The approval was based on a New Drug Application (NDA) that contained data from eight double-blind, placebo-controlled clinical studies involving about 3,800 patients with type 2 diabetes.
Tradjenta is currently under regulatory review in the EU and Japan. The product will be available as a tablet that can be taken with or without food.
"This approval provides another treatment option for the millions of Americans with Type 2 diabetes," said Mary Parks, director of the Division of Metabolism and Endocrinology Products in the FDA's Center for Drug Evaluation and Research. "It is effective when used alone or when added to existing treatment regimens."
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