Japan-based Takeda Pharma has received positive CHMP opinion for its three new type 2 diabetes therapies from the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP).
The therapies include Vipidia (alogliptin), a dipeptidyl peptidase IV (DPP-4) inhibitor; and for the fixed dose combination (FDC) therapies Vipdomet (alogliptin-metformin) and Incresync (alogliptin-pioglitazone) for the treatment of type 2 diabetes patients, who are not controlled under the existing therapies.
Takeda Pharma Europe & Canada commercial operations head Trevor Smith said due to patients failing to reach treatment objectives, the number of people at risk from complications associated with type 2 diabetes continues to increase throughout Europe.
"This positive opinion marks an important milestone in Takeda's ongoing commitment in working to advance patient care and helping to meet the individual needs of this growing patient population," Smith added.
The CHMP opinion was based on data from a clinical trial program for the treatment of disease comprising over 11,000 patients was carried out over the four years period, and two key studies, including ENDURE trial and the cardiovascular outcomes trial EXAMINE.
The efficacy of alogliptin was studied as an adjunct to diet and exercise as an add-on therapy to several other classes of anti-diabetic medications, including metformin, pioglitazone, insulin and sulfonylureas (SUs).
In these studies alogliptin 25mg 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.
