FDA approves GSK's Tanzeum to treat type 2 diabetes
Published on Apr 16, 2014 12:10 AM
(REUTERS) - The US Food and Drug Administration approved GlaxoSmithKline Plc's Tanzeum injection for treating adults with type 2 diabetes, in combination with diet and exercise.
Tanzeum will carry a warning on its label that tumors of the thyroid gland were observed in rodent studies with some drugs belonging to the same class. However, it is unknown whether Tanzeum causes thyroid C-cell tumors, the FDA said on its website.
The once-weekly drug, generically known as albiglutide, was approved last month in Europe, where it will be marketed as Eperzan.
Tanzeum belongs to the same class of injectable GLP-1 drugs as Victoza from Novo Nordisk and Byetta and Bydureon from AstraZeneca.