Merck a leading science and technology company, announced that the British Medicines and Healthcare products Regulatory Agency (MHRA), has approved on November 2 an updated labeling for Glucophage® XR (extended release metformin) for the treatment of patients with type 2 diabetes. The label change removes moderate renal impairment stage 3a and stable chronic heart failure from the list of the contraindications of Glucophage® XR.
In the case of Glucophage® XR the label changes were approved via a Worksharing Procedure in the European countries involved, where the UK was acting as the Reference Member State. The decisions are based on analyses of Merck's extensive efficacy and safety data collected over many years as well as new clinical studies available for Glucophage®, which was first registered in 1959.
Luciano Rossetti, Head of Global Research and Development at Merck´s biopharma business commented: "We are pleased with the update to the indications of Glucophage® XR and Glucophage® IR in the treatment of type 2 diabetes patients with moderate renal impairment stage 3a and in patients with stable chronic heart failure. Metformin is the first line treatment for patients with type 2 diabetes as recommended by international guidelines1,2. We are therefore pleased that more patients can now benefit from this treatment."
Until now Glucophage® IR and Glucophage® XR were contraindicated when glomerular filtration rate (GFR) was below 60ml/min. However, extensive postmarketing and clinical study evidence presented to the regulatory authorities supported that use of Glucophage® XR and Glucophage® IR has an acceptable safety profile in type 2 diabetic patients with moderate renal impairment stage 3a (when GFR is between 45ml/min and 59ml/min) at a reduced dose (max. 1000 mg/day), with no higher risk of adverse events.
A number of studies have demonstrated that the use of Glucophage® in the treatment of type 2 diabetes patients with stable chronic congestive heart failure has an acceptable safety profile4,5,6,7. Until now metformin was contraindicated in heart failure in general due to the potential risk of lactic acidosis, a risk factor in acute worsening heart failure.
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