The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended Boehringer Ingelheim (BI) and Eli Lilly and Company’s single-pill combination therapy with empagliflozin/metformin hydrochloride (HCl) to treat adults with type 2 diabetes (T2D).
The firms have received positive opinion from CHMP for the new therapy that will be marketed under the name Synjardy in Europe if approved.
Subject to approval, empagliflozin/metformin HCl will be available in the twice-daily doses in Europe, including 5mg empagliflozin plus 850mg or 1,000mg metformin HCl and 12.5mg empagliflozin plus 850mg or 1,000mg metformin HCl.
Empagliflozin/metformin HCl aggregates the sodium glucose cotransporter 2 (SGLT2) inhibitor, empagliflozin and metformin HCl within a single tablet.
Empagliflozin is the ingredient in Jardiance tablets that already obtained approval in the European Union, while metformin HCl is commonly prescribed to treat T2D.
The positive opinion was based on the clinical data from seven Phase III clinical trials, which included around 4,500 patients with T2D.
The studies investigated the efficacy and safety data of empagliflozin, as well as metformin either alone or in combination with other blood glucose-lowering drugs such as pioglitazone, sulfonylurea, DPP-4 inhibitors and insulin.
According to BI, the trials demonstrated that 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.