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.
Alogliptin is part of the DPP-4 class of diabetes drugs, which works by controlling blood sugar. Whitehouse Station, N.J.-based Merck & Co. already markets a drug in that class, called Januvia, while New York-based Bristol-Myers Squibb Co. and London-based AstraZeneca received FDA approval for their drug Onglyza in July.
Other potential competitors in the diabetes drug market include drugs from the GLP-1 class, which also control blood sugar. They include San Diego-based Amylin Pharmaceuticals Inc. and Indianapolis-based Eli Lilly & Co.'s exenatide LAR, which is a long-lasting version of the current drug Byetta. Denmark-based Novo Nordisk meanwhile is seeking approval for its GLP-1 drug, liraglutide.
Shares of Pharmaceutical Product Development lost 13 cents to $20.09 in morning trading.
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