Takeda, PPD To Begin Safety Study On Diabetes Drug

NEW YORK (AP) — Takeda Pharmaceutical Co. Ltd. said Friday it will start a study to assess the cardiovascular risks for its developing diabetes alogliptin, delaying any regulatory application by about two years.

The Japanese drug developer said the Food and Drug Administration agreed to the study design. The study was requested by the agency as part of the drug approval process.

In December, the FDA instituted tougher cardiovascular safety standards for diabetes drugs and in March Takeda said those standards would apply to its application for alogliptin. In June, Takeda confirmed the FDA would not approve the drug, lacking a cardiovascular safety study.

Takeda is developing alogliptin with Wilmington, N.C.-based Pharmaceutical Product Development Inc.

"We are committed to conducting this study to satisfy the cardiovascular safety requirements, leading to the enhancement of the product profile of alogliptin," said Dr. Nancy Joseph-Ridge, general manager of the pharmaceutical development division at Takeda.

The company expects to submit interim results that should meet criteria for approval in about two years.