DARMSTADT, Germany, October 14, 2016 /PRNewswire/ --
Not intended for U.S. and UK-based media
Merck, a leading science and technology company, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending 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 will lift the contraindication for stable moderate renal failure CKD stage 3. The maximum daily metformin dose will be 2000 mg/day in CKD stage 3a (GFR = 45-59 ml/min) and 1000 mg/day in CKD stage 3b (GFR = 30-44 ml/min), allowing 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.
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"We are pleased to know that the EMA review now confirms that metformin can be safely used in patients with moderate renal failure," said Luciano Rossetti MD, Executive Vice President, Global Head of Research & Development at the biopharma business of Merck. "We are proud of our heritage in the diabetes space that spans nearly 60 years, and began by bringing metformin to market. Since then we, and others, have continued to research on this product, and metformin 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 based on scientific evidence and clinical guidelines, patients with moderate renal failure may stand to benefit from treatment with metformin, and that the contraindication may therefore no longer be justified. Furthermore, the contraindication in CKD3a differed in metformin-containing products across Europe, as Merck had been granted a lift of the contraindication in CKD stage 3a recently. Based on this evidence, the 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 data on the efficacy and safety of metformin in patients with CKD stage 3. This was balanced against a cumulative analysis of all case reports Merck has received for lactic acidosis, the very rare risk associated with metformin accumulation due to acute or severe renal failure. The EMA reviewed the data submitted by all companies, and as a result, the CHMP has issued a positive opinion on lifting the contraindication for treatment of type 2 diabetes patients with renal impairment CKD stage 3.
Once approved by the European Commission, the Glucophage® product portfolio and Glucovance® will adopt this lift of contraindication for type 2 diabetes patients with moderate renal failure (CKD stage 3) through a label change. Glucophage® is already today on label in patients with CKD stage 3a in Europe and CKD stage 3 in Switzerland.
Glucophage® (metformin hydrochloride) is a prescription-only medicine indicated for the treatment of type 2 diabetes mellitus, particularly in overweight patients when diet and exercise alone have failed. In adults, Glucophage® may be given alone or with oral antidiabetic agents, or with insulin. In children from 10 years old and adolescents, Glucophage® may be given alone or with insulin. A reduction of diabetic complications has been shown in overweight type 2 diabetic adult patients treated with Glucophage® as first-line therapy after diet failure. The most commonly reported side effects with Glucophage® are gastro-intestinal disturbances that may occur during treatment initiation and resolve spontaneously in most cases.
The Glucophage® product portfolio comprises: Glucophage® IR (immediate release) and Glucophage® XR (extended release). In addition, Merck produces Glucovance® a fixed dose combination of metformin and glibenclamide.
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Merck is a leading science and technology company in healthcare, life science and performance materials. Around 50,000 employees work to further develop technologies that improve and enhance life - from biopharmaceutical therapies to treat cancer or multiple sclerosis, cutting-edge systems for scientific research and production, to liquid crystals for smartphones and LCD televisions. In 2015, Merck generated sales of € 12.85 billion in 66 countries.
Founded in 1668, Merck is the world's oldest pharmaceutical and chemical company. The founding family remains the majority owner of the publicly listed corporate group. Merck holds the global rights to the Merck name and brand. The only exceptions are the United States and Canada, where the company operates as EMD Serono, MilliporeSigma and EMD Performance Materials.
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