FDA Requests More Data on Alogliptin

Megan Brooks

April 27, 2012

April 27, 2012 — The US Food and Drug Administration (FDA) has requested more data before rendering a decision on new drug applications for alogliptin and fixed-dose combination alogliptin and pioglitazone, Takeda Pharmaceutical Company announced last week.

As reported by Medscape Medical News, the FDA previously turned down Takeda's application for alogliptin in June 2009, citing insufficient cardiovascular safety data. The company resubmitted applications for both alogliptin and the alogliptin/pioglitazone combination in July 2011.

Takeda has been in discussions with the FDA and believes it can supply to the agency postmarketing data from outside the United States, as well as data from its ongoing clinical trial program, the company notes in a news release dated April 25.

"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 US, if approved," said Thomas Harris, vice president, regulatory affairs, Takeda Global Research & Development Center, Inc.

Alogliptin is a selective dipeptidyl peptidase IV inhibitor (DPP-4) under investigation in the United States for the treatment of type 2 diabetes as an adjunct to diet and exercise. The drug slows the inactivation of incretin hormones GLP-1 (glucagon-like peptide-1) and GIP (glucose-dependent insulinotropic peptide) involved in regulating blood glucose levels.

Alogliptin was approved in Japan in April 2010 for treatment of type 2 diabetes, and it is currently available under the brand name Nesina.

"The 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-4 inhibitor and the thiazolidinedione pioglitazone in a single tablet," Takeda noted in its statement.

The fixed-dose combination alogliptin and pioglitazone was approved in Japan in July 2011 and is currently sold under the brand name Liovel.

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