A new single-pill combination therapy developed by Boehringer Ingelheim and Eli Lilly to treat adults with type 2 diabetes received a positive opinion for approval by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). The announcement was made following the presentation of data collected during seven Phase 3 clinical trials that enrolled over 4,500 patients with type 2 diabetes.
According to a press release from Boehringer Ingelheim, “Empagliflozin when added to metformin HCl lowers blood glucose, body weight, and blood pressure.” This new therapy will be given the name SYNJARDY® for marketing in Europe.
During clinical trials, adult patients with type 2 diabetes were given empagliflozin and metformin with or without additional blood glucose-lowering medications such as pioglitazone, sulfonylurea, DPP-4 inhibitors, or insulin. The goal was to study both efficacy and safety of treating patients with type 2 diabetes–SYNJARDY is not intended for patients with type 1 diabetes or diabetic ketoacidosis.
The numerous clinical trials identified a statistically significant reduction in blood glucose, body weight, and blood pressure. These results were accompanied by only mild side effects, namely hypoglycaemia when the combination was taken with insulin or sulphonylurea. No new safety issues were reported–only those already associated with empagliflozin and metformin HCl.
One tablet of SYNJARDY consists of empagliflozin, a sodium glucose cotransporter 2 (SGLT2) inhibitor, and metformin HCl, a commonly prescribed drug for treating type 2 diabetes. Four formulations are expected to become available in Europe: 5 mg empagliflozin with 850 mg or 1 g metformin HCl or 12.5 mg empagliflozin with 850 mg or 1 g metformin HCl. The pills are designed for twice-daily therapy.
Boehringer Ingelheim and Eli Lilly have worked together since January 2011 to study treatments for diabetes. They have one combination therapeutic already on the market in Europe, and adding SYNJARDY clearly demonstrates the co-commitment of these companies to helping patients with diabetes.
“Taking social responsibility is an important element of the corporate culture at Boehringer Ingelheim,” said a representative from Boehringer Ingelheim in the press release. “The focus of the family-owned company, founded in 1885, is researching, developing, manufacturing, and marketing new medications of high therapeutic value for human and veterinary medicine.” Indeed, adding SYNJARDY to this list of medications will be of great value to type 2 diabetic patients.