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Metformin products, including Glucophage approved for type 2 diabetes patients with moderate renal impairment in Europe

European Commission decision confirms Metformin for treatment in type 2 diabetes patients with moderate renal impairment, which will lead to extended treatment access.

Merck, a leading science and technology company, today announced that the European Commission (EC) has authorized the extension of the label for all metformin-containing products, including the Glucophage product portfolio and Glucovance, for the treatment of type 2 diabetes patients. The label change lifts the contraindication for stable moderate renal failure CKD (chronic kidney disease) stage 3, but adds some dose limitations. This change allows a large additional group of type 2 diabetes patients with reduced kidney function to benefit from the treatment: In a recent analysis in CPRD, a UK medical record database, 32.7% of all diabetic patients had CKD stage 3, with 23.2% in CKD stage 3a and 9.5% in CKD stage 3b.

Metformin products, including Glucophage approved for type 2 diabetes patients with moderate renal impairment in Europe

“We are pleased to see that the decision of the European Commission now confirms metformin can be safely used in type 2 diabetic patients with moderate renal failure,” said Luciano Rossetti, Executive Vice President, Global Head of R&D at the biopharma business of Merck. “Since we brought Glucophage to the market we, and others, have continued to research on metformin, which is now amongst the best investigated oral medications for type 2 diabetes. The lift of the contraindication is, at least in part, also a result of our research, and it further supports the safe and effective use of metformin as first line treatment in patients with type 2 diabetes.”

Following a routine evaluation of the safety of metformin medicines, it was found that patients with moderate renal failure may stand to benefit from treatment with metformin based on scientific evidence and clinical guidelines, and that the contraindication may therefore no longer be justified. The European Medicines Agency (EMA) issued an Article 31 referral requesting a cumulative review of the benefit and risk in this patient group across all metformin-selling companies in the European Union. Leveraging around 60 years of experience in market as the metformin originator, Merck supported the EMA request by providing a comprehensive analysis of all available clinical and post-marketing data on the efficacy and safety of metformin in patients with CKD stage 3. The data submitted by all companies was reviewed by EMA and as a result, the CHMP issued a positive opinion on lifting the contraindication for treatment of type 2 diabetes patients with renal impairment CKD stage 3 in October.

Following the EC decision the Summary of Product Characteristics (SmPC) will be updated to include details about the use of Metformin in type 2 diabetic patients with moderate renal failure in all Merck products containing metformin such as Glucophage, Glucophage XR, Stagid and Glucovance. Glucophage is already today on label in patients with CKD stage 3a in Europe and CKD stage 3a and b in Switzerland.

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