Boehringer Ingelheim and Eli Lilly and Co. (LLY) announced they have received a positive opinion from the European Medicines Agency's or EMA medicinal committee recommending approval of Jentadueto (linagliptin/metformin hydrochloride) tablets, a medicine combining the DPP-4 inhibitor, linagliptin (the active ingredient in Tradjenta tablets, marketed under the trade name Trajenta in Europe) and metformin in a single tablet taken twice daily.
The EMA's Committee for Medicinal Products for Human Use or 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 will provide a new, single-tablet treatment option, taken twice daily, for adults with type 2 diabetes who need to improve control of their blood glucose.
The company said Jentadueto was approved by the U.S. Food and Drug Administration or FDA in January 2012 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.
At the maximum dose of 2.5 mg (linagliptin)/1000mg (metformin HCl) BID, Jentadueto demonstrated placebo-corrected reductions in A1C levels of up to 1.7 percent (+0.1 percent for placebo and -1.6 percent for Jentadueto).
The companies said Adverse reactions reported in greater than or equal to five percent of patients treated with Jentadueto and more commonly than in patients treated with placebo included nasopharyngitis (the common cold) and diarrhea.
Linagliptin (5 mg, once daily) is marketed as Trajenta across Europe and Canada, as Tradjenta in the US, and Trazenta in Japan, as well as in additional markets.
The companies noted that Jentadueto is a prescription medicine that contains 2 diabetes medicines, linagliptin and metformin. Jentadueto can be used along with diet and exercise to help control blood sugar in adults with type 2 diabetes when treatment with both linagliptin and metformin is appropriate.
The companies stated that Jentadueto is not for people with type 1 diabetes or for people with diabetic ketoacidosis (increased ketones in the blood or urine).
It is not known if Jentadueto is safe and effective when used with insulin, the companies said.
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