GlaxoSmithKline’s Avandamet receives new approval

GlaxoSmithKline (GSK), the UK’s largest pharmaceutical company, has revealed that its treatment for type two diabetes, Avandamet, has been approved by the FDA as a first-line treatment as an adjunct to diet and exercise.

Avandamet is a combination therapy involving rosiglitazone maleate (available in the UK as Avandia) and metformin. Although it has been approved for use in the US as a second-line therapy in patients whose diabetes remained uncontrolled using a metformin monotherapy, the new indication makes Avandamet the only rosiglitazone maleate and metformin combination approved as an adjunct to diet and exercise.

The decision means that patients can start their treatment using Avandamet.

Anne M Phillips, vice-president of GSK’s clinical for North America cardiovascular-metabolic division, remarked: “GSK is committed to developing diabetes therapies to treat a disease that has reached epidemic proportions in the United States and throughout the world.”

“With the approval of Avandamet for use as initial therapy as an adjunct to diet and exercise, GSK offers this effective and convenient option now for initial treatment of type two diabetes,” she added.

Earlier this week, Avandamet was approved by the Scottish Medicines Consortium for restricted use in Scotland as part of a triple oral therapy with a sulphonylurea for glycaemic control in patients who are taking a dual oral therapy or in cases where they are unable to take insulin.

According to Diabetes UK, a charity, doctors can choose to prescribe Avandamet, despite the drug not yet having been appraised by NICE.

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