In case the European Commission (EC) approves the recommendation, the label of alogliptin as a therapy of Type 2 diabetes would include cardiovascular (CV) safety findings.
The committee's positive opinion for each of the three drugs includes updated results from two clinical trials. Proposed changes to the SmPC for all therapies include further data from the CV safety outcomes study, EXAMINE, of alogliptin plus standard of care versus placebo plus standard of care in 5,380 patients with Type 2 diabetes and recent acute coronary syndrome (ACS) with high underlying CV risk.
Furthermore, the proposed changes for Vipidia and Vipdomet include updated results from the three-arm, multi-centre, randomised, double-blind, active-controlled ENDURE trial, which assessed the durability of the safety and efficacy of once-daily alogliptin versus glipizide, each in combination with metformin, in patients with Type 2 diabetes.
Vipidia, Vipdomet and Incresync were initially authorised by the EC in September 2013.
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