EU approves Vipdomet for Type 2 Diabetes patients

The European Commission has granted Marketing Authorization (MA) for for the fixed-dose combination (FDC) therapy Vipdomet (alogliptin with metformin), from Takeda, for the treatment of Type 2 Diabetes patients who are uncontrolled on existing therapies. Approval was based on data from a 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.

Results from the ENDURE study demonstrated that alogliptin 25 mg in addition to metformin offered superior durability of glycemic control at two years with notably fewer hypoglycemic episodes and no negative impact on weight compared to a sulphonylurea (SU). Results also showed that when alogliptin was given in combination with metformin, significantly more patients achieve target HbA1c of below 7% compared with an SU in combination with metformin.