Biotech Values

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Takeda Receives Complete Response Letter from the FDA for Type 2 Diabetes Investigational Therapies Alogliptin and Fixed-Dose Combination Alogliptin and Pioglitazone

Takeda Pharmaceutical Company 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 under 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.

http://www.takeda.com/pdf/usr/default/press/NewsRelease_45507_1.pdf