Osaka, The Food and Drug Administration (FDA) in the United States rejected Takeda Pharmaceutical Co’s (TYO: 4502) application to market its new diabetes drug, citing insufficient data.
The largest pharmaceutical company in Japan will now have to provide more data on cardiovascular risks associated with the drug named Alogliptin.
Takeda spokesman Hisashi Tokinoya said, “We expect to resubmit the application in about two years. We’re still negotiating the design of the test with the FDA and hope to reach agreement in the near future.”
Big blow to Takeda
The rejection is sure to spoil Takeda President Yasuchika Hasegawa’s applecart. Hasegawa wanted Alogliptin to become a cash cow for the pharmaceutical giant.
Takeda’s present diabetes treatment, Actos, a top seller, will lose patent protection in 2011. Alogliptin was expected to be its successor.
“We expect to lose patent protection on Actos, and with the decision by the FDA it’s difficult to have the drug in time for the patent expiration," Tokinoya added.
No surprise
The FDA had, way back in March, requested for an additional study and more safety data from Takeda on the drug.
The Osaka, Japan based Takeda had applied to the FDA to sell Alogliptin, or SYR-322, in December 2007. The drug is meant to be a once-daily treatment for Type-2 diabetes.
Last week, the FDA reiterated its stance that the clinical data on Alogliptin was not enough based on new guiding principles on diabetes management and cardiovascular risks.
Therefore, the company and the stock markets expected a delay in the approval of the drug.
Kumi Miyauchi, an analyst at Daiwa Institute of Research, said, “The delay itself was not a surprise. But we now expect a further one year delay from the previously expected deadline of March 2012 in the drug's approval, as the company has not yet begun the needed additional study, which will take two years."
The new guidelines released December apply to all experimental diabetes drugs, whether studies are in progress or the medicine has been submitted for an FDA approval.
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