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. Earlier in the year, the French regulatory authority
Agence Nationale de Sécurité du Médicament et des Produits de Santé
(ANSM), had already approved an update of the labeling for Glucophage®
IR (immediate release metformin) removing the same contraindications.
The label changes apply to all countries in the European Union.
Glucophage® IR is approved by a Mutual Recognition Procedure, where
France acted as the Reference Member State. 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.
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.
Until now Glucophage® IR and Glucophage® XR were contraindicated when
glomerular filtration rate (GFR) was below 60ml/min. However, extensive
post-marketing 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 profile. 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.
In 2013, 382 million people were suffering from diabetes globally, and by 2035 this figure is predicted to rise to 592 million.
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 profile. 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.
In 2013, 382 million people were suffering from diabetes globally, and by 2035 this figure is predicted to rise to 592 million.
