FDA approves combo diabetes drug Jentadueto and Kalydeco

The US Food and Drug Administration) has approved Jentadueto (linagliptin/metformin hydrochloride) tablets, a new tablet combining the dipeptidyl peptidase-4 (DPP-4) inhibitor, linagliptin and metformin, developed by German family-owned drug major Boehringer Ingelheim and USA-based Eli Lilly (NYSE: LLY) for the treatment of type 2 diabetes. The news lifted Lilly’s shares by 1.2% to $39.70 in late trading on Monday.

Jentadueto provides a new, single-tablet treatment option, taken twice-daily, for patients who need to control their blood sugar. Linagliptin (5mg, once-daily) is marketed in the USA as Tradjenta and as Trajenta in Europe. The drug was approved by the FDA and the European Medicines Agency last year (The Pharma Letters May 4 and August 26, 2011).

Jentadueto is a prescription medication 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. At the maximum dose, Jentadueto demonstrated placebo-corrected reductions in hemoglobin A(1c) (HbA(1c) or A1C) levels of up to 1.7% (+0.1% for placebo and -1.6% for Jentadueto. A1C is measured in people with diabetes to provide an index of blood sugar control for the previous two to three months