Takeda Pharmaceutical Co., Asia’s biggest drugmaker, failed to win clearance to sell its new diabetes treatment in the U.S., with regulators asking for more information on the use of the medicine in other countries.
The request came in a so-called complete response letter from the Food and Drug Administration, Osaka, Japan-based Takeda said in a statement today. The necessary data can be supplied from information collected outside the U.S. and from patient studies under way, the company said.
The rejection of the drug, known chemically as alogliptin, to treat type-2 diabetes, derails Takeda President Yasuchika Hasegawa’s plan for it to be a new revenue generator when its best-selling diabetes treatment Actos loses patent protection in four months. The application was initially rejected in 2009, when the FDA asked for more data on cardiovascular risks.
Thursday, April 26, 2012
Takeda’s Successor Drug to Actos Fails to Win Approval - Bloomberg
via bloomberg.com
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