Updated on 21 June 2012
Singapore: Japan-based Takeda Global Research & Development Centre has received confirmation of the acceptance of submissions of marketing authorisation applications (MAAs) from the European Medicines Agency (EMA) for alogliptin and pioglitazone, which combines alogliptin with pioglitazone in a single tablet, and alogliptin and metformin, which combines alogliptin with metformin in a single tablet. The EMA has confirmed that the submissions have been validated for assessment.
"Takeda has been committed to researching and developing new therapies for the type 2 diabetes population for nearly 20 years, and we are confident that these submissions are another step towards helping patients in Europe who might benefit from the right combination of treatments," said Stuart Dollow, M.D., managing director, Takeda Global Research & Development Centre (Europe) Ltd. "If approved, these two new therapies both offer the benefit of combining two medications in one, which may reduce the number of pills patients must take each day."
Alogliptin is a dipeptidyl peptidase IV inhibitor (DPP-4i) being investigated, as an adjunct to diet and exercise, for the treatment of type 2 diabetes. DPP-4 inhibitors address insulin deficiency by slowing the inactivation of incretin hormones GLP-1 (glucagon-like peptide-1) and GIP (glucose-dependent insulinotropic peptide). As a result, an increased amount of active incretins enables the pancreas to secrete insulin in a glucose-dependent manner, thereby assisting in the management of blood glucose levels.
Pioglitazone is a thiazolidinedione (TZD) that directly addresses insulin resistance, a condition in which the body does not efficiently use the insulin it produces to control blood glucose levels, and is approved in adults for the treatment of type 2 diabetes, as an adjunct to diet and exercise. If approved, alogliptin and pioglitazone will be a new type 2 diabetes treatment option that includes both a DPP-4i and a TZD in a single tablet for patients in the EU.