EU approves Vipidia for Type 2 Diabetes patients

The European Commission has granted Marketing Authorization for Vipidia (alogliptin), from Takeda, for the treatment of Type 2 Diabetes patients who are uncontrolled on existing therapies. This announcement comes after publication of final results from the cardiovascular safety outcomes trial EXAMINE in The New England Journal of Medicine (NEJM). Approval was based on data from a robust clinical trial program involving more than 11,000 patients treated for up to four years and two key studies the ENDURE trial and interim data from the cardiovascular safety outcomes trial EXAMINE.

The efficacy of alogliptin was also studied as an adjunct to diet and exercise as an add-on therapy to several other classes of anti-diabetic medications, including metformin, thiazolidinediones, insulin and SUs. In these studies alogliptin 25 mg tablets taken once daily, demonstrated clinically and statistically significant reductions in HbA1c, with a good overall tolerability profile and low incidence of hypoglycemia compared with active control or placebo. Common adverse events reported with alogliptin include upper respiratory tract infection, nasopharyngitis, headache, abdominal pain, gastroeosophageal reflux (GERD), pruritus and rash.