Takeda Pharmaceutical Company Limited (Takeda) and its wholly-owned subsidiary, Takeda Global Research & Development Center, Inc. today announced that the company received a complete response letter from the United States (U.S.) Food and Drug Administration (FDA) regarding New Drug Applications (NDAs) for alogliptin and fixed-dose combination (FDC) alogliptin and pioglitazone.
Recently, Takeda provided postmarketing data from outside the U.S., and has been in discussion with the FDA. The FDA has requested additional data which Takeda believes it can supply to the Agency from postmarketing data from outside the U.S., as well as data from its ongoing clinical trial program.
"We will immediately request a meeting with the FDA to determine the appropriate next steps and are committed to addressing outstanding issues. We remain confident in the benefit that alogliptin will bring to patients with type 2 diabetes in the U.S., if approved," said Thomas Harris, vice president, regulatory affairs, Takeda Global Research & Development Center, Inc. "Takeda has built a strong foundation in and maintained a robust focus on diabetes over the past 20 years, and we will continue to invest in developing a diverse range of innovative products for the growing type 2 diabetes population."