Delivering a blow, the U.S. Food and Drug Administration (FDA) has asked Takeda Pharmaceuticals North America Inc. to conduct an additional heart-safety trial of alogliptin, its Type 2 diabetes experimental drug.
 
It remains unclear, whether Takeda will again have to submit its drug for approval to FDA, as treatment for Type 2 diabetes, the most common form of diabetes, in which the body does not produce enough insulin or does not use it effectively.  People with Type 1 diabetes virtually produce no insulin of their own.
 
Scrutiny of diabetes drugs has intensified after studies two years ago revealed Avandia, increased the risk of heart attacks in patients taking the once-popular diabetes pill.  Avandia and Takeda’s already on the market Actos, belong to a class of drugs known as thiazolidinediones or TZDs.
 
Takeda’s alogliptin is a part of a newer and increasingly popular class of drugs called DPP-4 inhibitors.  New Jersey drug giant Merck & Co.’s Januvia, a leading brand in that class generated $1.4-billion in worldwide sales last year.
 
Takeda’s drug patents for Actos, with $4-billion in annual global sales, begin to expire within the next two years, leaving the market open for competition from cheaper generics, eroding its diabetes drug sales.
 
Takeda Pharmaceutical Co. Ltd., is not only Japan’s largest drugmaker, but also the parent of the Deerfield operation - Takeda Pharmaceuticals North America Inc.