EMA recommends the approval of linagliptin as an oral treatment for type 2 diabetes
The Committee of Medicines for Human Use (CHMP) of the European Medication Agency (EMA, also in English) recommends the authorization of the oral drug linagliptin for type 2 diabetes, developed by the pharmaceuticals Boehringer Ingelheim and Lillyand whose commercial name will be suit .
Specifically, the favorable opinion is for the treatment with a unique daily dose of 5 milligrams of this drug, as a monotherapy treatment for patients with insufficient glycemia control, only with a diet and exercise guideline and forwhich is not adequate the treatment with metformin by intolerance or contraindications due to renal failure.
Likewise, the authorization of linagliptine has also been recommended as a complementary treatment to metformin and the metformin association plus a sulfonylurea, since this drug reduces the concentration of hemoglobin A1C (HBA1C) in an average of between -0.6 and-0.7%, compared to placebo.
The favorable opinion has been based on a clinical trial program in which some 6,000 adults with type 2 diabetes participated, which had four placebo controlled studies that evaluated linagliptin as a treatment in monotherapy and in association with the oral antihyperglycemicism prescribed with moreFrequency, metformin and a sulfonylurea.
This drug was authorized in the United States in May 2011 and, according to the clinical director of the Diabetes and Endocrinology Department of the University of Birmingham (United Kingdom), Anthony Barnett, "studies demonstrate the remarkable efficacy of linagliptin, as well as its favorableSecurity and tolerability profile. "
"In addition, it is mainly eliminated through bile ducts and the intestine, that is, an adjustment of the dose is not necessary in patients with decline of renal or hepatic function," he says.