GlaxoSmithKline plc (GSK, GSK.L) said Tuesday that the U.S. Food and Drug Administration has approved Tanzeum subcutaneous injection as a once-weekly treatment for type 2 diabetes.
Tanzeum has been approved as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Tanzeum is a glucagon-like peptide-1 receptor agonist, a hormone that helps normalize blood sugar levels. The drug's safety and effectiveness were evaluated in eight clinical trials involving more than 2,000 patients with type 2 diabetes.
Tanzeum has a boxed warning to warn that tumors of the thyroid gland have been observed in rodent studies with some GLP-1 receptor agonists, but that it is unknown whether Tanzeum causes thyroid C-cell tumors, including a type of thyroid cancer called medullary thyroid carcinoma, in humans.
GlaxoSmithKline expects to launch Tanzeum in the U.S. in the third quarter of 2014.
GlaxoSmithKline shares closed Tuesday's regular trading session at $52.32, up 48 cents. The company's shares closed 0.26% higher at 1,547.00 pence in London.
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