EMA’s CHMP Recommends BI/Lilly Diabetes Combo Drug
Boehringer Ingelheim (BI) and Eli Lilly and Company (Lilly) 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, 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 and already being treated with the combination of empagliflozin and metformin as separate tablets.
Source: Boehringer Ingelheim