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Takeda gains CHMP nod to update labels of Vipidia, Vipdomet and Incresync
29 July 2014 - 29 July 2014 - Takeda Pharmaceuticals International GmbH, part of Japanese Takeda Pharmaceutical Co Ltd (TYO:4502), said Tuesday it had secured positive opinions from the European Committee for Medicinal Products for Human Use (CHMP) to update the Summary of Product Characteristics (SmPC) for Vipidia (alogliptin) and the fixed-dose combination (FDC) drugs, Vipdomet (alogliptin and metformin) and Incresync (alogliptin and pioglitazone).

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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