EMA approval for metformin in patients with renal impairment
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 to included patients with stable moderate renal failure (chronic kidney disease 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. The product information for these medicines will be updated to revise the current contraindication and give information about doses, monitoring and precautions in patients with reduced kidney function.
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. 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 companies selling metformin companies in the European Union. 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.
EMA summary on metformin in moderate renal failure