Takeda Pharmaceutical Company Limited announced that Takeda Global Research and Development Center, Inc, a wholly-owned United States (US) subsidiary, was informed as part of regular discussions about the alogliptin New Drug Application (NDA) with the United States Food and Drug Administration (FDA), that although the alogliptin NDA was filed prior to issuance of FDA's December 2008 guidance on new type-2 diabetes treatments, the FDA will apply these guidelines when reviewing the alogliptin NDA.
Additionally, the FDA does not believe that the amount of existing alogliptin clinical data is sufficient to meet certain statistical requirements in the new guidance. The agency is open to discussions regarding the design of additional CV studies with alogliptin. Alogliptin's Prescription Drug User Fee Act (PDUFA) date - June 26, 2009 - remains unchanged.
In December, 2008 the FDA issued 'Guidance for Industry: Diabetes Mellitus - Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat type-2 Diabetes'.
In October 2008, Takeda received notification from the FDA that it was unable to complete its review of the alogliptin NDA by the original PDUFA date - October 27, 2008 - due to internal resource constraints. The FDA did not raise any issues with the data in the alogliptin NDA at that time. In December 2007, Takeda submitted its NDA for alogliptin to the FDA.
Alogliptin, which was discovered by Takeda's wholly-owned US subsidiary, Takeda San Diego, Inc. is a dipeptidyl peptidase IV (DPP-4) inhibitor being reviewed as an adjunct to diet and exercise for the treatment of type 2 diabetes.
DPP-4 inhibitors inhibit the enzyme dipeptidyl peptidase IV (DPP-4), which metabolizes the insulin-increasing hormones glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic peptide (GIP).