Merck’s Glucophage XR gets regulatory nod for type 2 diabetes patients

Germany’s Merck KGaA (MRK: DE) on Tuesday said the UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved an updated labelling for Glucophage XR (extended release metformin) for type 2 diabetes patients with moderate renal impairment stage or stable chronic heart failure.

Luciano Rossetti, head of global research and development at Merck´s biopharma business, said: “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 guidelines. We are therefore pleased that more patients can now benefit from this treatment.”

Earlier in the year, the French regulatory authority Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM), approved an update of the labelling for Glucophage IR (immediate release metformin) removing the same contraindications.