Takeda Pharmaceutical Co. Ltd. Receives FDA Complete Response Letter for the Investigational Fixed-Dose Combination of alogliptin and ACTOS(R) (pioglitazone HCl) for the Treatment of Type 2 Diabetes

DEERFIELD, Ill. and OSAKA, Japan, Sept. 4 /PRNewswire/ -- Takeda Pharmaceutical Company Limited ("Takeda") today announced that its wholly owned subsidiary, Takeda Global Research & Development Center, Inc. (U.S.), received on September 2 (U.S. TIME), a complete response letter from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for the fixed-dose combination (FDC) of alogliptin and ACTOS(R) (pioglitazone HCl). The FDA informed Takeda on June 26, 2009 that further review of the alogliptin monotherapy NDA would be conditional based upon additional data from a cardiovascular (CV) safety study that satisfies the statistical requirements of the December 2008 FDA Guidance titled, "Guidance for Industry: Diabetes Mellitus - Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes."