New diabetes therapy receives final FDA approval
Basaglar (insulin glargine injection) is a long-acting therapy that can help control blood sugar -- which can lead to better quality of life and fewer complications for diabetes patients.
The therapy was approved after two clinical trials involving 534 and 744 patients living with type 1 and type 2 diabetes. It is a once-daily treatment administered via single-dose "quick pens." It was granted tentative FDA approval in Aug. 2014.
“Long-acting insulin products like insulin glargine play an important role in the treatment of types 1 and 2 diabetes mellitus, and (Basaglar's) approval is expected to expand the availability of treatment options for health care professionals and patients,” Dr. Jean-Marc Guettier said.
Guettier is the director of the Division of Metabolism and Endocrinology Products at FDA’s Center for Drug Evaluation and Research.
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