Boehringer Ingelheim and Eli Lilly and Company today 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 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 and metformin, which is commonly prescribed for the treatment of T2D. If approved, this will be the second single-pill combination therapy Boehringer Ingelheim and Eli Lilly will offer in Europe through their diabetes alliance.

Empagliflozin when added to metformin lowers blood glucose, body weight and blood pressure. Side effects identified with empagliflozin plus metformin were in line with the known safety profile of the individual compounds empagliflozin and metformin.

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.

The positive opinion is based on the submission of robust clinical data from seven Phase III clinical trials that enrolled over 4,500 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.

Empagliflozin/metformin is not intended to be used in patients with type 1 diabetes or for diabetic ketoacidosis. Subject to approval, empagliflozin/metformin is expected to be available in the following twice-daily doses like 5mg empagliflozin plus 850mg or 1000mg metformin and 12.5mg empagliflozin plus 850mg or 1000mg metformin in Europe.