Boehringer Ingelheim and Eli Lilly have received a positive opinion from the European Medicines Agency's (EMA) medicinal committee recommending approval of Jentadueto (linagliptin/metformin hydrochloride) tablets, a medicine combining the DPP-4 inhibitor linagliptin and metformin in a single tablet taken twice daily .
The EMA's Committee for Medicinal Products for Human Use (CHMP) recommended the approval of Jentadueto for use alongside diet and exercise to improve glycemic control in adults with type 2 diabetes who are inadequately controlled on their maximally tolerated dose of metformin alone or those already being treated with the combination of linagliptin and metformin. If approved by the European Commission, Jentadueto would provide a single-tablet treatment option, taken twice daily, for adults with type 2 diabetes who need to improve control of their blood glucose, according to the Ridgefield, Conn.-based Boehringer and the Indianapolis-based Lilly.
Jentadueto was approved by the FDA in January as a prescription medicine used along with diet and exercise to improve glycemic control in adults with type 2 diabetes when treatment with both linagliptin and metformin is appropriate.
During its trial phase, adverse reactions were reported in 5 percent or more of patients treated with Jentadueto and more commonly than in patients treated with placebo. Hypoglycemia was more commonly reported in patients treated with the combination of Jentadueto and sulfonylurea compared with those treated with the combination of placebo, sulfonylurea and metformin, the companies said. Pancreatitis was reported more often in patients randomized to linagliptin (one per 538 person-years vs. zero in 433 person-years for comparator).
Linagliptin (5 mg, once daily) is marketed as Trajenta across Europe and Canada, as Tradjenta in the U.S., and Trazenta in Japan, as well as in additional markets.