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Feb 25, 2013
 |  BC Week In Review  |  Clinical News  |  Regulatory

Tradjenta regulatory update

Germany's Federal Joint Committee (G-BA) said in a final benefit assessment that diabetes drug Trajenta linagliptin from Boehringer Ingelheim provides no additional benefit over sulfonylurea. G-BA said that Boehringer did not submit suitable studies evaluating Trajenta as monotherapy and for Trajenta in combination with sulfonylurea and metformin. The committee did accept a study comparing Trajenta plus metformin vs. glimepiride, a sulfonylurea, plus metformin. Based on the study, G-BA said that while there was a lower incidence of non-fatal stroke in patients receiving Trajenta, the committee questioned the result's "clinical relevance" due to...

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