Dec. 24 (Bloomberg) -- Takeda Pharmaceutical Co., Asia’s biggest drugmaker, may have to wait eight months longer than expected for U.S. regulators to decide whether to approve a new diabetes drug, planned to replace its best-seller Actos.

The U.S. Food and Drug Administration will respond to the application to sell alogliptin, as the experimental medicine is called, by June 26, 2009, compared with an initial deadline of last Oct. 27, Osaka, Japan-based Takeda said today in a statement.

Chief Executive Officer Yasuchika Hasegawa, 62, is counting on the product to help buffer an expected decline in sales of Actos, the world’s best-selling diabetes drug, when it loses patent protection in 2011. The FDA initially delayed the review “due to internal resource constraints,” Takeda said Oct. 10. The agency failed to meet its timetable on at least 15 drugs so far this year, according to data through October compiled by Corey Davis, an analyst with Natixis Bleichroeder in New York.

“It’s an FDA matter,” Ayako Iwamuro, a spokeswoman for Takeda, said today by telephone. “They didn’t ask us for any additional data.” The company “can’t speculate” on what effect the new date may have on sales or earnings, Iwamuro said.

Takeda fell 1.3 percent to 4,480 yen at the close on the Tokyo Stock Exchange, valuing the company at 3.65 trillion yen ($40.4 billion). The stock has dropped 32 percent this year, more than the 25 percent decline for the MSCI World Health-Care Index of 116 companies.

To contact the reporter on this story: Nicolas Johnson in Tokyo at nicojohnson@bloomberg.net.

Last Updated: December 24, 2008 01:08 EST