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news.Boehringer Ingelheim and Eli Lilly and Company have received a positive opinion from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) recommending approval of a single-pill combination therapy with empagliflozin/metformin hydrochloride (HCl) to treat adults with type 2 diabetes (T2D).
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Following approval, the new therapy will be marketed under the name Synjardy in Europe.
The single-pill therapy is a combination of the sodium glucose cotransporter 2 (SGLT2) inhibitor, empagliflozin and metformin HCl, which is commonly prescribed to treat T2D.
If approved by the EMA, this will be the second single-pill combination therapy the companies will offer in Europe as part of their diabetes alliance.
Empagliflozin is the active ingredient in Jardiance tablets, which are already approved in the European Union (EU).
The EMA positive opinion is based on data from seven Phase III trials involving more than 4,500 patients with T2D.
The trials evaluated the efficacy and safety data of empagliflozin plus metformin either alone or in combination with other blood glucose-lowering drugs (pioglitazone, sulfonylurea, DPP-4 inhibitors and insulin).
Results from these trials showed that treatment with empagliflozin 10mg and 25mg when added to metformin, with or without other standard blood glucose-lowering drugs, led to reductions in blood glucose, body weight and a clinically relevant reduction in blood pressure.
According to the company, empagliflozin/metformin HCl is not intended to be used in patients with type 1 diabetes or for diabetic ketoacidosis.
After securing approval in Europe, empagliflozin/metformin HCl will be made available in twice-daily doses including 5mg empagliflozin plus 850mg or 1000mg metformin HCl; and 12.5mg empagliflozin plus 850mg or 1000mg metformin HCl.
Image: Boehringer Ingelheim’s corporate headquarters in Ingelheim, Germany. Photo: courtesy of Boehringer Ingelheim GmbH.