TOKYO, - Takeda Pharmaceutical Co Ltd (4502.T), Japan's largest drugmaker, said U.S. health authorities have extended their review of a diabetes drug combining its top-selling Actos and experimental medicine alogliptin until September.
The combination pill is not expected to be approved after alogliptin last month failed to gain approval, with the U.S. Food and Drug Administration asking for additional safety tests, a process Takeda says could take two years.
Alogliptin, which belongs to a new class of diabetes drugs called DDP-4 inhibitors, has been positioned by Takeda as a successor to Actos, which will lose U.S. patent protection in 2011.
"The approval process for alogliptin by itself is separate from that of the fixed-dose combination," said Takeda spokeswoman Hisako Nagata.
"But it is difficult to think that the combination drug would receive approval prior to alogliptin by itself," she said.
There is currently only one DPP-4 diabetes drug on the U.S. market, Merck & Co's (MRK.N) Januvia.
The FDA said it will respond to Takeda's application for approval on Sept. 4, instead of July 22 as previously planned.
Shares of Takeda were down 0.5 percent at 3,670 yen, while the benchmark Nikkei average .N225 was up 0.4 percent.
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