Shares of Takeda Pharmaceutical, Japan’s largest drugmaker, fell on Monday after it said it expects a delay until March 2012 or later in U.S. approval of its key diabetes drug SYR-322 [ID:nSP468416].
Takeda said on Saturday it expects a delay in approval of the drug, which the stock market expected, after U.S. regulators repeated on Friday their request made originally in March for an additional study and more safety data from Takeda on the drug.Takeda reiterated it was still discussing with U.S. regulators details of an additional study on cardiovascular risks.
Analysts said the delay in approval of the successor to Takeda’s top-selling drug Actos by around two and a half years from the previously targeted deadline of Friday was generally expected after the regulators’ request in March.
Takeda shares fell 1.6 percent to 3,730 yen, underperforming sector rivals such as Astellas Pharma (4503.T), which dipped 0.6 percent, and Daiichi Sankyo (4568.T), which fell 0.5 percent.
reuters.com
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