Takeda says it has received a complete response letter from the FDA regarding NDAs (new drug applications) for alogliptin and fixed-dose combination alogliptin and pioglitazone – both diabetes type 2 investigational therapies. Takeda says it has recently been providing the FDA (Food and Drug Administration) with postmarketing data from markets outside the USA. Takeda believes it can provide the additional information from postmarketing data from non-USA markets, as well as findings from its current clinical trial program.
Thomas Harris, vice president, regulatory affairs, Takeda Global Research & Development Center, Inc., said:
“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.
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 DPP-4i (selective dipeptidyl peptidase IV inhibitor). It is an investigational drug for diabetes type 2 treatment in the USA, alongside exercise and diet.
Alogliptin slows down the inactivation of GLP-1 (glucagon-like peptide-1) and GIP (glucose-dependent insulinotropic peptide). GLP-1 and GIP are incretin hormones which are involved in regulating blood glucose levels.
The most common adverse effects linked to alogliptin, according to a phase 3 program, include upper respiratory tract infection, headache, urinary tract infection, and nasopharyngitis.
Drugs containing pioglitazone have been available in the United States since 1999 for diabetes type 2 treatment, alongside exercise and diet.
In a communiqué online, Takeda wrote:
“The FDC (fixed dose combination) 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.”
Adverse events related to alogliptin and pioglitazone co-administration include influenza, urinary tract infection, back pain and nasopharyngitis.
According to the Wall Street Journal, shares of Furiex Pharmaceuticals Inc. dropped 26%. Furiex is a partner drug developer with Takeda.
Written by Christian Nordqvist