CHMP recommends empagliflozin / metformin hydrochloride for approval in the EU for the treatment of Type 2 Diabetes

Boehringer Ingelheim (BI) and Eli Lilly and Company (Lilly) have 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, when added to metformin HCl, lowers blood glucose, body weight and blood pressure

Empagliflozin/metformin HCl combines within a single tablet the sodium glucose cotransporter 2 (SGLT2) inhibitor, empagliflozin 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 positive recommendation 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 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

For more information about BI,  please visit www.boehringer-ingelheim.com.

To find out more about Lilly Diabetes, please visit www.lillydiabetes.com.