More data needed for Takeda’s alogliptin
FDA will apply its December 2008 guidelines on cardiovascular risk assessment for type 2 diabetes drugs in its review of Takeda's DPP-4 inhibitor alogliptin, despite the fact that the drug company submitted its NDA prior to the published guidance. The agency informed Takeda March 6 that the amount of existing alogliptin clinical data is not sufficient to meet certain statistical requirements in the new guidance. In October 2008, the agency notified the drug company that it could not meet the PDUFA date due to internal resource constraints, but did not raise any issues with the data (1"The Pink Sheet" DAILY, Dec. 29, 2008). Takeda's new user fee date is June 26
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Takeda announced June 27 that U.S. FDA had denied approval of its type 2 diabetes agent alogliptin, a potential blockbuster poised to compete with similar molecules from Merck and the team of Bristol-Myers Squibb and AstraZeneca. The setback will delay alogliptin's launch by at least three years - and possibly longer - depending on the additional studies required by regulators
Takeda announced April 21 it would discontinue clinical development of diabetes agent TAK-379 because it did not meet internal criteria to support further development. An insulin sensitizer, TAK-379 was in Phase II trials in the U.S. and Europe and in Phase I in Japan
FDA may be heeding stakeholder calls to set new action dates once an original user fee deadline is missed.