FDA approves new diabetes drug
The FDA approved linagliptin to treat adults with type 2 diabetes – the form of the disease that affects between 90% and 95% of the 96 million people in the United States who have diabetes.
Linagliptin (Tradjenta, Boehringer Ingelheim Pharmaceuticals Inc.) tablets are intended for use with diet and exercise to improve blood glucose control. The medication can be prescribed in conjunction with other type 2 diabetes therapies, including metformin, glimepiride and pioglitazone.
Linagliptin works by stimulating the release of insulin after a meal by blocking dipeptidyl peptidase-4, and has been demonstrated safe and effective in eight double blind, placebo-controlled studies involving 3,800 patients with type 2 diabetes.
“This approval provides another treatment option for the millions of Americans with type 2 diabetes,” Mary Parks, MD, director of the Division of Metabolism and Endocrinology Products in the FDA's Center for Drug and Evaluation Research, said in a press release. “It is effective when used alone or when added to existing treatment regimens.”
The most common adverse events include upper respiratory infection, stuffy or runny nose, sore throat, muscle pain and headache.