FDA issues complete response letter to Takeda’s NDAs for type 2 diabetes investigational therapies

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."

Alogliptin is a selective dipeptidyl peptidase IV inhibitor (DPP-4i) under investigation in the U.S. for the treatment of type 2 diabetes as an adjunct to diet and exercise. Alogliptin is designed to slow the inactivation of incretin hormones GLP-1 (glucagon-like peptide-1) and GIP (glucose-dependent insulinotropic peptide), which play roles in regulating blood glucose levels. The FDC alogliptin and pioglitazone combines two complementary agents with distinct mechanisms of action, and if approved, will be the first type 2 diabetes treatment option in the U.S. to include both a DPP-4i and the thiazolidinedione (TZD) pioglitazone in a single tablet. Pioglitazone-containing medicines have been available in the U.S. since 1999 for the treatment of type 2 diabetes as an adjunct to diet and exercise.

The most common adverse events (>/=5% and greater than placebo) reported in the alogliptin phase 3 program include headache, urinary tract infection, nasopharyngitis, and upper respiratory tract infection. With regard to the co-administration of alogliptin and pioglitazone, common adverse events (>/=5%) reported include nasopharyngitis, back pain, urinary tract infection, and influenza.

Takeda will share material information about the next steps when it becomes possible to do so.


Takeda Pharmaceutical Company Limited


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