CHMP recommends updates for Vipidia, Vipdomet and Incresync for T2D - Takeda

The EMA's Committee for Medicinal Products for Human Use (CHMP) has issued positive opinions for updates to the Summary of Product Characteristics (SmPC) for Vipidia (alogliptin) and the fixed-dose combination therapies Vipdomet (alogliptin and metformin) and Incresync (alogliptin and pioglitazone), from Takeda, for patients with Type 2 Diabetes. The CHMP recommendation for each of these therapies includes updated findings from two clinical studies. Proposed changes to the SmPC for Vipidia, Vipdomet, and Incresync include additional information from the CV safety outcomes trial EXAMINE in which cardiovascular outcomes were studied for Alogliptin vs. standard of care in Patients with T2D and Acute Coronary Syndrome.

Additionally, the proposed changes for Vipidia and Vipdomet also include updated findings from the ENDURE which looked at afty and efficacy of Alogliptin plus Metformin vs Glipizide plus Metformin in Subjects With T2D. EXAMINE was conducted with 5,380 patients, with recent ACS and high underlying CV risk. EXAMINE evaluated the effect of treatment with alogliptin in addition to standard of care, versus placebo in addition to standard of care, on major adverse CV events. ENDURE was a three-arm, multi-center, randomized, double-blind, active-controlled study evaluating the durability of the safety and efficacy of once-daily alogliptin compared to glipizide, each in combination with metformin.