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EMA clears GSK's diabetes therapy Eperzan

Once-weekly GLP-1 therapy will line-up against Victoza and Byetta

GlaxoSmithKline (GSK) 

GlaxoSmithKline says it will launch its once-weekly diabetes therapy Eperzan in the EU later this year after winning approval for the GLP-1 agonist from the European Medicines Agency (EMA).

Eperzan (albiglutide) has been approved to improve glucose control in type 2 diabetes patients both as a monotherapy when diet and exercise alone are not sufficient and treatment with metformin is not advised, as well as in combination with other glucose-lowering drugs including insulin.

Eperzan joins a GLP-1 agonist market that is currently led by Novo Nordisk's Victoza (liraglutide) and AstraZeneca's Byetta (exenatide) - both of which are given once-daily - as well as a weekly formulation of exenatide called Bydureon which was launched in 2011.

Novo Nordisk stopped trials of a once-weekly formulation of Victoza in 2012 after it emerged it was not as effective as daily dosing, and has now switched its attention to a longer-acting formulation of a different GLP-1 agonist called semaglutide in phase 3 testing.

Meanwhile, Eli Lilly has its much-touted once-weekly dulaglutide already filed for approval while Sanofi is preparing to submit its own long-acting candidate lixisenatide next year.

All the GLP-1 agonists are designed to boost the production of the body's own insulin and are tipped to become a $5bn product category in the next few years, fuelled by the longer-acting formulations.

Predicting the ultimate winners in the category is difficult and analyst expectations vary, although Victoza's current dominance of the short-acting sector with sales of $2.2bn last year is expected to be maintained in the medium term.

Meanwhile, Lilly's dulaglutide has been tipped to be a strong player among the once-weekly products, and AZ is sounding increasingly bullish on prospects for its own franchise following the launch of Bydureon Pen in the US.

Predictions for albiglutide sales have been fairly modest at around $400m-$500m a year, thanks in part to studies which showed it was not as effective as pioglitazone in controlling blood sugar as well as mixed results in comparative trials with Victoza.

GSK is also in the final stages of regulatory review of Eperzan in the US, with an FDA verdict due on April 15 after a short delay.

Article by
Phil Taylor

27th March 2014

From: Sales

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