TOKYO, Oct 10 (Reuters) - Takeda Pharmaceutical Co (4502.T), Japan’s biggest drugmaker, said on Friday that U.S. health authorities have not been able to complete a review of a key diabetes drug candidate on schedule due to lack of resources.
The drug, called alogliptin or SYR-322, is critical to Takeda’s mainstay diabetes business as it is expected to be the main replacement for its best-selling Actos.
Actos, which generates almost 30 percent of Takeda’s sales, will lose U.S. patent protection in 2011.
The U.S. Food and Drug Administration did not ask for more information on alogliptin, raise any issues with data or provide any guidance on when a review might be completed, a Takeda spokeswoman said.
The review had been scheduled to finish on Oct. 27.
Industry analysts have said the prasugrel delay was most likely due to a backlog at the FDA or perhaps small issues with the labelling.
Alogliptin belongs to a new class of diabetes drugs called DPP-4 inhibitors, and Takeda hopes it will compete with rival drug Januvia from Merck & Co (MRK.N).
Takeda has also sought U.S. approval for an alogliptin-Actos combination pill. (Reporting by Sachi Izumi; Editing by Edwina Gibbs)