US approval for Glaxo’s Tanzeum
GlaxoSmithKline has gained FDA approval for its new diabetes treatment Tanzeum.
The drug is the latest contender in the GLP-1 class of diabetes treatments, and is taken once a week for controlling type 2 diabetes.
Tanzeum (albiglutide) will compete with Novo Nordisk’s once-a-day GLP-1 Victoza (liraglutide), AstraZeneca’s twice-daily Byetta (exenatide) and Bydureon, an extended-release formulation of the latter, Byetta.
Albiglutide was approved in Europe last month, under the brand name Eperzan.
The FDA approval of albiglutide is based on the results of GSK’s comprehensive Phase III Harmony programme, consisting of eight trials and involving over 5,000 patients, over 2,000 of whom were treated with Tanzeum. The Harmony studies evaluated albiglutide against commonly-used classes of type 2 diabetes treatment, including insulin, metformin, glimepiride and pioglitazone, in patients at different stages of the disease, as well as those with renal impairment.
GSK anticipates the US launch of Tanzeum in the third quarter of 2014.
Like other drugs in the class, Tanzeum must carry boxed warnings about the risk of thyroid C-cell tumours, and further warnings and precautions about pancreatitis and hypoglycemia.
Despite its more convenient once-weekly formulation, data for the drug is less compelling than market leader Victoza. Albiglutide failed to beat Victoza in a head-to-head study in 2011.
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