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CHMP recommends empagliflozin/metformin HCl for approval in the EU


30 March, 2015  

Boehringer Ingelheim (BI) and Eli Lilly and Company (Lilly) announced they have received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), recommending approval of a single-pill combination therapy with empagliflozin/metformin hydrochloride (HCl) for the treatment of adults with type 2 diabetes (T2D).

If approved, the new therapy will be marketed under the name Synjardy® in Europe.

Empagliflozin/metformin HCl combines within a single tablet the sodium glucose cotransporter 2 (SGLT2) inhibitor, empagliflozin (the active ingredient in Jardiance® tablets, already approved in the European Union (1)) and metformin HCl, which is commonly prescribed for the treatment of T2D. If approved, this will be the second single-pill combination therapy BI and Lilly will offer in Europe through their diabetes alliance.

The CHMP has recommended approval of the single-pill combination therapy for use alongside diet and exercise to improve blood glucose control in adults with T2D when they are:

  • Inadequately controlled with metformin alone or in combination with other blood glucose-lowering drugs
  • Already being treated with the combination of empagliflozin and metformin as separate tablets

About the Phase III Clinical Trials (2)
The positive opinion is based on the submission of robust clinical data from seven Phase III clinical trials that enrolled over 4500 patients with T2D. These studies investigated the efficacy and safety data of empagliflozin plus metformin either alone or in combination with other blood glucose-lowering drugs (pioglitazone, sulphonylurea, DPP-4 inhibitors and insulin).

The results showed that treatment with empagliflozin (10mg and 25mg) when added to metformin, with or without other standard blood glucose-lowering drugs, led to statistically significant reductions in blood glucose, body weight and a clinically relevant reduction in blood pressure.

The most common side effect reported by patients in the clinical trials was hypoglycaemia (low blood glucose) in combination with insulin and/or sulphonylurea. In general, the adverse event profile of empagliflozin plus metformin HCl was in line with the known safety profile of the individual compounds empagliflozin and metformin.

The common side effects experienced with empagliflozin are urinary tract and genital yeast infections, increased urination and itching. The common side effects experienced with metformin are nausea, vomiting, diarrhoea, abdominal pain, loss of appetite and taste disturbance.

References:

  1. Jardiance® (empagliflozin) tablets. EMA Summary of Product Characteristics. Approval 22 May 2014. Available from: www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information….
  2. Boehringer Ingelheim. Data on File.